Open-Label Study of Safety of H1337 in Healthy Volunteers
An Open-Label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of H1337 Ophthalmic Solution, 1% in Healthy Volunteers
1 other identifier
interventional
17
1 country
1
Brief Summary
The trial will evaluate the safety of one dose regimen of H-1337 \[1% twice daily (b.i.d.)\] in both eyes in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2024
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2024
CompletedFebruary 11, 2025
October 1, 2024
28 days
August 22, 2024
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events Reporting [Safety and Tolerability]
Incidence of ocular and systemic adverse events
Screening through Day 9
Study Arms (1)
H-1337 1.0% Ophthalmic Solution b.i.d.
EXPERIMENTALOne drop H-1337 twice daily in the both eyes for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult male or female subjects
- Subjects in good ocular and systemic health with clinically insignificant medical and ophthalmic history
You may not qualify if:
- Chronic or acute ophthalmic disease in each eye including but not limited to any form of glaucoma, retinal diseases, clinically significant cataract (primary or secondary)
- Recent intraocular surgery in either eye (within 6 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Research Foundation Inc.
Newport Beach, California, 92663, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2024
First Posted
August 27, 2024
Study Start
September 16, 2024
Primary Completion
October 14, 2024
Study Completion
October 14, 2024
Last Updated
February 11, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share