A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults

NCT05969236 | Completed Phase 1 FDA Drug

• 1 other identifier: MDI-1228-I-AC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles\* of MDI-1228\_mesylate Ophthalmic Solution in healthy adult participants. Participants will receive either of the following treatment:

• MDI-1228\_mesylate Ophthalmic Solution, or
• Placebo\*\* Researchers will observe any changes in health (if any) in participants receiving the study treatment to evaluate the safety and tolerability\*\*\* of the study drug. Researchers will also collect several blood samples from participants to study PK profiles of the drug. Note: \*PK profiles: how the drug interacts with the body. \*\*placebo: a harmless substance that contains no active agents. \*\*\*tolerability: how well you can tolerate the drug.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (96)

• Part A and B - Incidence and severity of all systemic or ocular treatment emergent adverse events (TEAEs)

  Systemic or ocular TEAEs will be collected from spontaneous reports and direct observation. The investigator will make an assessment of intensity for each TEAE and assign it to one of the Common Terminology Criteria for Adverse Events (CTCAE) categories: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).

  From first dose to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of vital sign measurement results - respiratory rate

  Respiratory rate (breaths/minute) will be measured while the participant is at rest in a supine or semi-supine position (after ≥ 5 minutes resting supine or semi-supine), to monitor and record any abnormal clinically significant changes from baseline and incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of vital sign measurement results - heart rate

  Heart rate (beats/minute) will be measured while the participant is at rest in a supine or semi-supine position (after ≥ 5 minutes resting supine or semi-supine), to monitor and record any abnormal clinically significant changes from baseline and incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of vital sign measurement results - blood pressure

  Blood pressure (mmHg) will be measured while the participant is at rest in a supine or semi-supine position (after ≥ 5 minutes resting supine or semi-supine), to monitor and record any abnormal clinically significant changes from baseline and incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of vital sign measurement results - body temperature

  Body temperature (℃) will be measured while the participant is at rest in a supine or semi-supine position (after ≥ 5 minutes resting supine or semi-supine), to monitor and record any abnormal clinically significant changes from baseline and incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - general appearance

  Assessment of general appearance (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - head, eyes, ears, nose, and throat (HEENT)

  Assessment of HEENT (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - neck (including thyroid and nodes)

  Assessment of neck (including thyroid and nodes) (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - cardiovascular system

  Assessment of cardiovascular system (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - respiratory system

  Assessment of respiratory system (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - gastrointestinal system

  Assessment of gastrointestinal system (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - renal system

  Assessment of renal system (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - neurological system

  Assessment of neurological system (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - musculoskeletal system

  Assessment of musculoskeletal system (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of physical examination results - skin

  Assessment of skin (normal/abnormal) will be performed at screening, and may be performed at various scheduled/unscheduled time points if deemed necessary by the Investigator, to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of 12-lead electrocardiogram (ECG) results - heart rate

  12-lead ECG measurements will be performed to monitor and record any abnormal clinically significant changes in heart rate (beats/min) as well as the result interpretation from baseline and incidence of such changes after treatment until the last visit. All ECG measurements will be recorded in triplicate (repeat for 3 times), with 1- to 2-minute intervals between ECG readings.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of 12-lead ECG results - PR interval

  12-lead ECG measurements will be performed to monitor and record any abnormal clinically significant changes in PR interval (milliseconds) as well as the result interpretation from baseline and incidence of such changes after treatment until the last visit. All ECG measurements will be recorded in triplicate, with 1- to 2-minute intervals between ECG readings.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of 12-lead ECG results - QRSD interval

  12-lead ECG measurements will be performed to monitor and record any abnormal clinically significant changes in QRSD interval (milliseconds) as well as the result interpretation from baseline and incidence of such changes after treatment until the last visit. All ECG measurements will be recorded in triplicate, with 1- to 2-minute intervals between ECG readings.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of 12-lead ECG results - QT interval corrected with Fridericia Formula (QTcF)

  12-lead ECG measurements will be performed to monitor and record any abnormal clinically significant changes in QTcF (milliseconds) as well as the result interpretation from baseline and incidence of such changes after treatment until the last visit. All ECG measurements will be recorded in triplicate, with 1- to 2-minute intervals between ECG readings.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Assessment of 12-lead ECG results - RR interval

  12-lead ECG measurements will be performed to monitor and record any abnormal clinically significant changes in RR interval (milliseconds) as well as the result interpretation from baseline and incidence of such changes after treatment until the last visit. All ECG measurements will be recorded in triplicate, with 1- to 2-minute intervals between ECG readings.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - corrected visual acuity (CVA)

  CVA (measured using Snellen chart) will be assessed to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - intraocular pressure

  Intraocular pressure (mmHg) will be assessed to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - light response pupil test

  Light response pupil test (positive/negative) will be performed to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - extraocular movement test

  Extraocular movement test will be performed to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - slit-lamp examination

  Slit-lamp examination will be performed to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - corneal fluorescein staining test

  Corneal fluorescein staining test will be performed to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Ophthalmic assessment - dilated fundus examination

  Dilated fundus examination will be performed at screening, Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes from baseline and the incidence of such changes after treatment until the last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - red blood cell distribution width

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in red blood cell distribution width (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - hemoglobin

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in hemoglobin (g/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - hematocrit

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in hematocrit (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - red blood cell count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in red blood cell count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - white blood cell count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in white blood cell count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - absolute neutrophil count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in absolute neutrophil count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - neutrophil percentage

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in neutrophil percentage (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - absolute lymphocyte count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in absolute lymphocyte count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - lymphocyte percentage

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in lymphocyte percentage (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - absolute monocyte count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in absolute monocyte count (cells/μL)) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - monocyte percentage

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in monocyte percentage (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - absolute basophil count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in absolute basophil count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - basophil percentage

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in basophil percentage (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - absolute eosinophil count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in absolute eosinophil count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - eosinophil percentage

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in eosinophil percentage (%) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - platelet count

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in platelet count (cells/μL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - mean cell hemoglobin

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in mean cell hemoglobin (pg/cell) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - mean cell volume

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in mean cell volume (fL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - mean cell hemoglobin concentration

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in mean cell hemoglobin concentration (g/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of hematology results - mean platelet volume

  Hematology tests will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in mean platelet volume (fL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of coagulation results - international normalized ratio (INR)

  A coagulation test will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in INR from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of coagulation results - activated partial thromboplastin time (aPTT)

  A coagulation test will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in aPTT (seconds) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of coagulation results - prothrombin time (PT)

  A coagulation test will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in PT (seconds) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - sodium

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood sodium (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - potassium

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood potassium (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - chloride

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood chloride (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - calcium

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood calcium (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - bicarbonate

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes from baseline in blood bicarbonate (mmol/L) and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - albumin

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes from baseline in blood albumin (g/dL) and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - total protein

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in total protein (g/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - creatinine

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood creatinine (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - creatine kinase

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood creatine kinase (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - estimated glomerular filtration rate (GFR)

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes from baseline in estimated GFR (mL/min) and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - urea

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood urea (μmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - aspartate aminotransferase (AST)

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in AST (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - alanine aminotransferase (ALT)

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in ALT (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - gamma glutamyl transpeptidase (GGT)

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in GGT (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - alkaline phosphatase (ALP)

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in ALP (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - phosphate

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood phosphate (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - total bilirubin

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in total bilirubin (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - direct bilirubin

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in direct bilirubin (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - indirect bilirubin

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in indirect bilirubin (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - amylase

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood amylase (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - cholesterol

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in cholesterol (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - high density lipoprotein (HDL)/cholesterol ratio

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in HDL/cholesterol ratio from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - high density lipoprotein (HDL) cholesterol

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in HDL cholesterol (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - low density lipoprotein (LDL) cholesterol/high density lipoprotein (HDL) cholesterol ratio

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in LDL/HDL cholesterol ratio from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - low density lipoprotein (LDL) cholesterol

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in LDL cholesterol (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - non-high density lipoprotein (HDL) cholesterol

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in non-HDL cholesterol (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - triglycerides

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in triglycerides (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - uric acid

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in uric acid (μmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - lactate dehydrogenase

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in lactate dehydrogenase (units/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - magnesium

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood magnesium (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - glucose

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in blood glucose (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - anion gap

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in anion gap (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - adjusted calcium

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in adjusted calcium (mmol/L) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of blood biochemistry results - globulin

  Blood biochemistry will be measured at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in globulin (g/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - pH

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in pH from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - specific gravity

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in specific gravity from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine glucose

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine glucose (negative/+/++/+++) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine protein

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine protein (negative/+/++/+++) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine bilirubin

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine bilirubin (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine ketones

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine ketones (negative/+/++/+++) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine blood

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine blood (negative/+/++/+++) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine nitrite

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine nitrite (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - urine urobilinogen

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in urine urobilinogen (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of urinalysis results - leucocyte esterase

  Urinalysis will be performed at screening, baseline (not required if screening assessment done within 3 days), Day 2 visit (Part A) or Day 8 visit (Part B) to monitor and record any abnormal clinically significant changes in leucocyte esterase (mg/dL) from baseline and the incidence of such changes after treatment until last visit.

  From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of scores of conjunctival hyperemia

  Scores of conjunctival hyperemia (0 to 4 scores, a higher score indicates a more severe condition) will be assessed to record the change from the pre-dose (Day -1) scores to the post-dose scores (Day 2 for Part A, Day 8 for Part B) in the study eye.

  From pre-dose to post-dose (Day 2 in Part A, Day 8 in Part B)

• Part A and B - Assessment of scores of corneal staining

  Scores of corneal staining (0 to 5 scores, a higher score indicates a more severe condition) will be assessed to record the change from the pre-dose (Day -1) scores to the post-dose scores (Day 2 for Part A, Day 8 for Part B) in the study eye.

  From pre-dose to post-dose (Day 2 in Part A, Day 8 in Part B)

Secondary Outcomes (14)

• Part A - Maximum concentration (Cmax) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution

  Post-first dose on Day 1 to EOS (Day 7±1 day)

• Part A and B - Time to maximum concentration (Tmax) of MDI-1228_mesylate Ophthalmic Solution

  Post-first dose on Day 1 to EOS (Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A and B - Half-life (T1/2) of MDI-1228_mesylate Ophthalmic Solution

  Post-first dose on Day 1 to EOS (Day 7±1 day in Part A, Day 14±1 day in Part B)

• Part A - Systemic clearance (CL or CL/F) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution

  Post-first dose on Day 1 to EOS (Day 7±1 day)

• Part A - Volume of distribution (Vd) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution

  Post-first dose on Day 1 to EOS (Day 7±1 day)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Including 2 single dose groups (Part A) and 2 multiple dose groups (Part B). Participants in experimental groups will receive MDI-1228\_mesylate Ophthalmic Solution.

Drug: MDI-1228_mesylate Ophthalmic Solution

Comparator Group

PLACEBO COMPARATOR

One comparator group will be set for each of the 4 experimental groups, to a total of 4 comparator groups. Participants in comparator groups will receive placebo.

Drug: Placebo

Interventions

MDI-1228_mesylate Ophthalmic Solution DRUG

MDI-1228\_mesylate Ophthalmic Solution includes 2 strengths: * 0.1% (0.4 mL \[0.4 mg\] free base) * 0.3% (0.4 mL \[1.2 mg\] free base)

Experimental Group

Placebo DRUG

The components employed in the placebo formulation are the same as those used for the active formulation except MDI-1228\_mesylate is absent.

Comparator Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weight ≥ 50 kg for males, ≥ 45 kg for females, with the BMI (BMI = weight\[kg\]/height\[m\]2) between 18 and 32 (inclusive) at screening.
• The corrected visual acuity (CVA) of both eyes should be 6/6 or 20/20 (Snellen chart), with an intraocular pressure between 10 and 21 mmHg (inclusive) and a difference in intraocular pressure between the 2 eyes \< 5 mmHg at screening.
• Normal vital signs after ≥ 5 minutes resting supine or semi supine position:
• ≥ 90 mmHg and ≤160 mmHg (systolic blood pressure)
• ≥50 mmHg and ≤ 95 mmHg (diastolic blood pressure)
• ≥ 45 beats per minute (bpm) and ≤ 100 bpm (heart rate)
• Body temperature ≥35.5℃ and ≤37.7℃
• Respiratory Rate≥12 breaths/minute and≤22 breaths/minute
• Standard 12-lead ECG parameters after ≥5 minutes resting in supine or semi-supine position with PR ≥ 120 ms and ≤ 220 ms, QRSD \< 120 ms, QTcF ≤ 450 ms for males and ≤ 470 ms for females, and otherwise normal ECG (all data limits are based on average readings of the ECGs) at screening.
• Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method as assessed by the PI (OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD) from screening until study completion, including the follow up period for at least 30 days after the last dose of study drug, or be post-menopausal for ≥ 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
• Males must be surgically sterile (\> 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method as assessed by the PI from screening until study completion, including the follow up period, for at least 30 days after the last dose of study drug. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long- acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse as part of their usual lifestyle and are not planning to conceive will also be eligible.
• Male participants must agree to refrain from donating sperm and female participants from donating ova from screening until study completion, including the follow up period, for at least 90 days after the last dose of study drug.
• Provides written informed consent and is willing and able to undergo all study procedures and attend the scheduled follow up visit/s per protocol.
• Are willing to consume clinical research unit (CRU) provided meals.

You may not qualify if:

• Have a current or past history of clinically significant circulatory system diseases, respiratory disorders, hepatobiliary disorders, digestive disorders, urinary system diseases, renal disorders, endocrine disorders, immune system disorders, malignancies, metabolic disorders, mental disorders, or nervous system diseases that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the participant by virtue of their participation in the study. Participant with a history of uncomplicated kidney stones (defined as spontaneous passage and no recurrence in the last 5 years); uncomplicated cholecystectomy; Gilbert's syndrome; a past history of being treated by non-current depression may be enrolled in the study at the discretion of the Investigator. Participants with a history of childhood asthma (without hospitalization) that has symptomatically resolved and remains untreated may participant.
• Have healed eye disorders (such as infection, trauma) in either eye within 1 month prior to the first dose.
• Have a history of intraocular surgery and laser eye surgery in either eye.
• Used any ocular products (including various eye drops or eye gel) within 14 days or 5 half-lives (whichever is longer) prior to screening.
• Wore contact lenses within 2 days prior to baseline (Day -1) or need to wear contact lenses throughout the clinical study.
• Current evidence or history of COVID-19 or influenza-like illness as defined by fever (\> 37.7°C) and 2 or more of the following symptoms within 7 days before dosing: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhea in the absence of a known cause, other than influenza or COVID-19 infection.
• A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
• Participants who are intolerant of venipuncture blood collection or have poor venous access and/or have a history of fear of needles and hemophobia.
• Used Janus kinase (JAK) inhibitors or immunosuppressants or any other prescription drugs, traditional Chinese medicines or Chinese patent medicines within 4 weeks prior to Day -1; or used over-the-counter (OTC) drugs or health products within 2 weeks prior to Day -1, unless with a washout period of more than 5 half-lives for products with a longer half-life. The Principal Investigator may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.
• Was vaccinated within 2 weeks prior to screening or plan to be vaccinated during the study.
• Had major surgery within 6 months prior to screening or plan to undergo surgery during the study.
• Participants who smoked more than 5 cigarettes/pipes/vaping per day on average or excessive use of any nicotine product (\> 5 products on average per day) within 3 months prior to screening and not able to abstain from smoking from screening to end of study (EoS).
• Any other serious medical condition or abnormality that, in the Investigator's judgment, precludes the participant's safe participation in and completion of the study.
• A positive pre-study drug or alcohol screen. A positive drug or alcohol screen test result may be verified by re-testing (up to 1 false positive result permitted) and may be followed up at the discretion of the Investigator.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \> 21 units for males or \> 14 units for females. One unit is equivalent to 10 g of alcohol and the following can be used as a guide: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (30 mL) measure of spirits.

Sponsors & Collaborators

• Shanghai Medinno Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sepehr Shakib, PhD

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

• Liang Lu, PhD

  Shanghai Medinno Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study consists of two parts: * Part A: Single ascending dose in healthy volunteers * Part B: Multiple ascending doses in healthy volunteers The randomization code and the randomization list will be generated using SAS version 9.4 or the latest available version at time of randomization.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: October 6, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)