Trials / Completed
CompletedNCT04928144
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Sunhawk Vision Biotech, Inc. · Industry
- Sex
- All
- Age
- 10 Years – 15 Years
- Healthy volunteers
- Accepted
Summary
This is a single-center, open-label, first-in-human dose-escalation study of SHJ002 Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional children will receive the highest tolerated concentration for 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHJ - Low concentration | Topical ophthalmic |
| DRUG | SHJ - Mid concentration | Topical ophthalmic |
| DRUG | SHJ - High concentration | Topical ophthalmic |
| DRUG | SHJ - Maximum tolerated | SHJ - Maximum tolerated |
Timeline
- Start date
- 2021-07-02
- Primary completion
- 2021-09-17
- Completion
- 2021-09-17
- First posted
- 2021-06-16
- Last updated
- 2022-03-23
Locations
1 site across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04928144. Inclusion in this directory is not an endorsement.