Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease

NCT04139122 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: SJP-0132/1-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease

Conditions

Dry Eye Disease; Dry Eye Syndrome

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events by Severity in Each Cohort

  Number of participants with adverse events by severity are summarize in each cohort. Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.

  Day 2 for cohort 1-4, Day 29 for cohort 5-6

• Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort

  Clinical laboratory parameters include hematology, clinical chemistry, urinalysis, and serology. Vital signs include diastolic blood pressure, systolic blood pressure, heart rate, respiratory rate, and body temperature. Ophthalmologic observations include examination of visual acuity, slit lamp biomicroscopy, Schirmer I, intraocular pressure, and ophthalmoscopy.

  Day 2 for cohort 1-4, Day 29 for cohort 5-6

• Maximum Plasma Concentration (Cmax)

  The results are from the maximum plasma concentration (Cmax) on Day 1. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1 for Cohorts 1 to 4. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1 for Cohorts 5 and 6.

  Day 1

• Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last)

  Area under the plasma concentration-time curves (AUCs) for Cohorts 1 to 4 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1, and those for Cohorts 5 and 6 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1.

  Day 1

• Accumulation Ratio (Rac) After Multiple Dosing

  Plasma were collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1, pre-dose on Day 2, Day 4 and Day 8. Accumulation ratios calculated as (predose plasma concentration \[Ctrough\] on Day 4) / (Ctrough on Day 2) and (Ctrough on Day 8) / (Ctrough on Day 2)

  Day 2, 4, 8

• Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29

  Visual analog scale (VAS): "0" mean none, and "100" mean the worst imaginable for the symptom question.

  Day 29

• Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29

  Change from baseline of central zone CFS score at the central zone on Day 29. CFS score at the central zone ranged from 0 to 5, where '0' represents no fluorescein staining, and '5' represents severe staining on the cornea. The higher scores mean worse outcomes. Results from the study eye are reported.

  Day 29

Secondary Outcomes (8)

• Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints

  Day 29

• Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints

  Day 8, 15, 22, 29

• Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints

  Day 8, 15, 22, 29

• Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints

  Day 8, 15, 22, 29

• Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints

  Day 8, 15, 22, 29

Study Arms (4)

Cohort 1-4: SJP-0132

EXPERIMENTAL

Each cohort will receive a single dose of 1 of 4 strengths of SJP-0132

Drug: SJP-0132

Cohort 1-4: Placebo

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

Cohort 5-6: SJP-0132

EXPERIMENTAL

Cohort 5 SJP-0132 will receive the second maximum acceptable dose from Cohorts 1-4 for 4 weeks. Cohort 6 SJP-0132 will receive the maximum acceptable dose from Cohorts 1-4 for 4 weeks

Drug: SJP-0132

Cohort 5-6: Placebo

PLACEBO COMPARATOR

Multiple dose placebo for 4 weeks

Drug: Placebo

Interventions

SJP-0132 DRUG

SJP-0132 is administered as an eye drop

Cohort 1-4: SJP-0132; Cohort 5-6: SJP-0132

Placebo DRUG

Placebo is administered as an eye drop

Cohort 1-4: Placebo; Cohort 5-6: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) within 18.5 to 30.0 kg/m2 (inclusive) and body weight between 45 kg and 100 kg
• Generally healthy as determined by medical history, physical examinations, clinical laboratory examination, and ophthalmologic examinations performed at Screening
• Have a subject reported history of Dry Eye Disease in both eyes for at least 6 months prior to Screening
• Non-smoker or ex-smoker for \>12 months

You may not qualify if:

• Have clinically significant systemic or ophthalmic disease
• Has a positive serum pregnancy test at Screening or urine pregnancy test
• Have had significant blood loss or have donated or received one or more units (450 mL) of blood or plasma within 30 days before randomization
• Have used or anticipates use of any prescription or over-the-counter medication, including topical medications such as ophthalmic solutions, nasal drops or spray, vitamins, alternative and complementary medicines (including herbal formulations) within 14 days or 5 half-lives (whichever is longer) before randomization or at any time during the study
• Use or anticipates use of prescribed dry eye medications within 28 days prior to randomization or at any time during the study
• Have used or anticipates use CYP3A4 inducers, such as St. John's Wort, within 14 days before randomization or at any time during the study.
• Have consumed red wine, grapefruit or grapefruit juice, Seville oranges, star fruit, or any products containing these items, or any foods that may inhibit CYP3A4, within 48 hours before randomization and throughout the duration of the study
• Have a positive urine alcohol or urine drug test at Screening or Day -1
• Contact lens wearers who cannot discontinue the wear over the trial period
• Have undergone eye surgery (including laser surgery) within the last 12 months or whom the Investigator considers unsuitable
• Have a best corrected visual acuity (BCVA) worse than 20/100 in either eye
• History of permanent punctal occlusion (cautery or laser) or current use of punctal plugs
• Any corneal abnormality or disease which might impact normal tear film spreading
• Active or history of significant corneal disease
• Known allergy or sensitivity to fluorescein, lissamine green or any of the study medications

Sponsors & Collaborators

• Senju Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Senju Investigational Site

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.

Results Point of Contact

• Title: Director, Clinical Development
• Organization: Senju Pharmaceutical Co. Ltd.

senju-clinicaltrials@senju.co.jp

+81 078 777 1018

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 25, 2019
• Study Start: October 5, 2019
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)