Trials / Completed
CompletedNCT04615325
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
A Phase 1a, Multicenter, Open-label, Single-dose, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RO7303359 | RO730359 will be administered as a single intravitreal injection. |
Timeline
- Start date
- 2020-12-08
- Primary completion
- 2023-01-04
- Completion
- 2023-01-04
- First posted
- 2020-11-04
- Last updated
- 2023-03-01
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04615325. Inclusion in this directory is not an endorsement.