Subcutaneous Administration of MD-18 in Healthy Subjects

NCT06259903 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MD-18-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A Single Center, Single Dose, Double-blind, Randomized, Placebo-controlled Dose-Escalating Study to Evaluate Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in healthy subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by the collection of Adverse Events.

  Adverse Events Collection.

  For all study duration (approximately two months).

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by the collection of pre and post dose pharmacokinetics samples.

  Pharmacokinetics sampling is predicated on a T1/2 less than 6 hours to enable inpatient monitoring for 4-5 half-lives.

  Before and after dose administration on Days 0 and 1.

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by the collection of vital signs.

  Systolic and diastolic blood pressure in millimeters of mercury, Heart rate in beats per minute, Respiratory rate in breath per minute.

  On screening visit and on days 1 and 7.

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by the collection of Lab samples.

  Collection of Complete blood count, Serum chemistry, Coagulation panel and Urine analysis.

  On screening visit and on days 1 and 7.

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by the collection of anthropometric measurement's.

  Weight in kilograms, Height in meters.

  On screening visit and on days 1 and 7. (height will be collected only in the screening visit).

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by an electrocardiogram examination.

  12-lead ECG will be obtained within 1 hour before and 3 hours (+15 minutes) after dosing and prior to discharge. The ECG machine will automatically calculate the heart rate, measure of the time from the beginning of the atrial depolarization to the beginning of the ventricular depolarization, depolarization of ventricles and time taken for ventricular depolarization and repolarization. At each time-point, ECG will be obtained in triplicate.

  On screening visit and on days 0,1 and 7.

• To determine the safety of a single subcutaneously administered dose of MD-18 in healthy subjects, as assessed by physical examination.

  A complete physical examination (head, eyes, ears, nose and throat, heart, lungs, abdomen, skin, cervical and axillary lymph nodes, neurological, and musculoskeletal systems) will be performed.

  On screening visit and on days 1 and 7.

Secondary Outcomes (1)

• Analysis of pharmacokinetics samples of MD-18 by lab methods.

  Before and after dose administration on Days 0 and 1.

Other Outcomes (3)

• Treatment-emergent Adverse Events (TEAEs) will be assessed.

  For all study duration ( approximately two months).

• Tolerability (referred to as the dose-limiting tolerability) will be assessed by the number of reported cases with nausea and injection site reaction.

  On days 0-3.

• Adverse events of special interest will be assessed.

  For all study duration ( approximately two months).

Study Arms (5)

40 milligram (mg) MD-18 OR 40 milligram(mg) Placebo

EXPERIMENTAL

A single dose of subcutaneous injection of 40mg MD-18 OR 40mg Placebo will be given on day zero.

Drug: MD-18

80 milligram (mg) MD-18 OR 80 milligram (mg) Placebo

EXPERIMENTAL

A single dose of subcutaneous injection of 80mg MD-18 OR 80mg Placebo will be given on day zero.

Drug: MD-18

160 milligram (mg) MD-18 OR 160 milligram (mg) Placebo

EXPERIMENTAL

A single dose of subcutaneous injection of 160mg MD-18 OR 160mg Placebo will be given on day zero.

Drug: MD-18

240 milligram (mg) MD-18 OR 240 milligram (mg) Placebo

EXPERIMENTAL

A single dose of subcutaneous injection of 240mg MD-18 OR 240mg Placebo will be given on day zero.

Drug: MD-18

320 milligram (mg)MD-18 OR 320 milligram (mg) Placebo

EXPERIMENTAL

A single dose of subcutaneous injection of 320mg MD-18 OR 320mg Placebo will be given on day zero.

Drug: MD-18

Interventions

MD-18 DRUG

Subcutaneous Administration of MD-18 in Healthy Subjects.

160 milligram (mg) MD-18 OR 160 milligram (mg) Placebo; 240 milligram (mg) MD-18 OR 240 milligram (mg) Placebo; 320 milligram (mg)MD-18 OR 320 milligram (mg) Placebo; 40 milligram (mg) MD-18 OR 40 milligram(mg) Placebo; 80 milligram (mg) MD-18 OR 80 milligram (mg) Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18-70 years, both genders.
• Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:
• Absence of clinically significant illness or surgery within the preceding 12 weeks.
• Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
• Male subjects with female partners of childbearing potential must agree to utilize an approved contraceptive during the study.
• Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use contraception during the study.
• Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).
• Body mass index (BMI) of 18.5-39.9 kg/m2

You may not qualify if:

• History of excessive alcohol use (defined as \>21 drinks per week for males and \>14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen. Note: use of Cannabinoids for medical purposes is allowed.
• Pregnant or breastfeeding within six months of screening assessment.
• Substantial changes in eating habits or exercise routine within the preceding three months.
• Evidence of eating disorders.
• \>5% weight change in the past three months.
• Bariatric surgery within the past five years.
• Significant renal impairment glomerular filtration rate (GFR) \<60 milligram/milliliter/1.73m2).
• Liver function tests (i.e., alanine aminotransferase, Aspartate Amino Transferase, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
• Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
• Use of drugs approved for the treatment of obesity.
• Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
• A baseline prolongation of ventricular activation and recovery interval after repeated measurements of \>450 millisecond; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
• Participation in an investigational drug trial within three months prior to dosing in the present study.

Sponsors & Collaborators

• Cohen Global, Ltd.: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Please Select, 522651, Israel

Location

Study Officials

• Amir Tirosh, Prof

  Cohen Global, Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study medication will be supplied in labelled vials, clearly identifying the contents and indicating that the product is an investigational drug. An unblinded pharmacist at the clinical site will be responsible for drawing up the appropriate amount of study medication into a syringe and labelling the syringe for administration to the specific patient according to the randomization scheme.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Five subjects in cohort 1 will be administered a single subcutaneous dose of 40 mg MD-18 and two will receive placebo. The cohort will be staggered with 2 active and one placebo patient treated on day 1 and the remainder on Day 3 if there are no safety concerns. The same dosing regimen will be observed for each incremental cohort, with the remaining planned doses being 80, 160, 240 and 320 milligram (mg).

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 14, 2024
• Study Start: May 7, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)