Trials / Active Not Recruiting
Active Not RecruitingNCT05835895
Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis
A Phase 1b, Randomized, Double-Blinded, Placebo-Controlled Dose Ranging Study to Evaluate Safety, Tolerability and Pharmacodynamics of a Single Intra-articular Injection of GNSC-001 Gene Therapy in Subjects With Osteoarthritis of the Knee
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Genascence Corporation · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | GNSC-001 | intra-articular injection |
| DRUG | transient immune-modulation | oral |
| DRUG | transient immune-modulation | intra-articular injection |
| DRUG | Placebo | intra-articular injection |
Timeline
- Start date
- 2023-06-12
- Primary completion
- 2025-04-08
- Completion
- 2029-05-01
- First posted
- 2023-04-28
- Last updated
- 2025-08-01
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05835895. Inclusion in this directory is not an endorsement.