Trials / Completed
CompletedNCT04246866
First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Gemini Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.
Detailed description
This is a Phase 1, multicenter, open-label, single-dose, dose-escalation study in subjects with GA secondary to dry AMD to investigate the safety, tolerability, pharmacodynamics (PD), and immunogenicity of IVT injections of GEM103 to a single eye. The study is designed to identify the MTD for IVT administration of GEM103. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of DLTs. Three escalating dose cohorts are planned. Subjects will undergo clinical and ophthalmic assessments for inclusion eligibility into the study. Enrolled subjects will receive GEM103 and be followed for safety, PK, clinical, and biomarker evaluations.
Conditions
- Dry Age-related Macular Degeneration
- Geographic Atrophy
- Macular Degeneration
- Retinal Disease
- Retinal Degeneration
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GEM103 | GEM103 |
Timeline
- Start date
- 2019-12-19
- Primary completion
- 2020-10-21
- Completion
- 2020-10-21
- First posted
- 2020-01-29
- Last updated
- 2021-02-11
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04246866. Inclusion in this directory is not an endorsement.