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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06572397

Enrollment

Registered

2024-08-27

Start date

2024-09-16

Completion date

2024-10-14

Last updated

2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Open-Angle Primary, Ocular Hypertension

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.

Interventions

DRUGH-1337 1.0%

ophthalmic solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult male or female subjects * Subjects in good ocular and systemic health with clinically insignificant medical and ophthalmic history

Exclusion criteria

* 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) Note: Other inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events Reporting [Safety and Tolerability]	Screening through Day 9	Incidence of ocular and systemic adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026