drugset / Trial / NCT04875754
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis
RandomizedSequentialQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 or matching placebo into the knee of subjects with mild to moderate knee osteoarthritis (OA).
Timeline
- Start
- 2022-03-17
- Primary completion
- 2026-03
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ICM-203 | Gene therapy (AAV / viral vector) | 6e+12 vg | Other |
| Subject | ICM-203 | Gene therapy (AAV / viral vector) | 2e+13 vg | Other |
| Subject | ICM-203 | Gene therapy (AAV / viral vector) | 6e+13 vg | Other |