Trials / Recruiting
RecruitingNCT05986864
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Skyline Therapeutics (US) Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | SKG0106 | SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product |
Timeline
- Start date
- 2024-02-23
- Primary completion
- 2026-01-01
- Completion
- 2026-01-30
- First posted
- 2023-08-14
- Last updated
- 2025-01-09
Locations
9 sites across 2 countries: United States, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05986864. Inclusion in this directory is not an endorsement.