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 (DONATELLO)

NCT05835895 Phase 1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Genascence Corporation
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	67
Start date	2023-06-12
Completion	2029-05

Conditions

• Osteoarthritis, Knee
• Osteo Arthritis Knee
• Knee Osteoarthritis

Interventions

• GNSC-001
• transient immune-modulation
• transient immune-modulation
• Placebo

Primary outcomes

• Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) — Month 12
• Severity of TEAEs and SAEs — Month 12

Countries

United States