Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06704932 | A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee | PHASE1 | COMPLETED | 32 | — | — | Nov 20, 2024 | Dec 18, 2025 | Jan 12, 2026 | 1 | Germany |
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE).
Count of PCSAs and descriptive statistics will be done on clinical laboratory, vital signs and 12-Lead ECG parameters.
| Arm | Type | Description |
|---|---|---|
| SAR446959 | EXPERIMENTAL | Participants will receive a single intra-articular dose of SAR446959 on Day 1 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single intra-articular dose of placebo on Day 1. The injection volume of the placebo will be the same as the injection volume for SAR446959 in the corresponding dose level cohort. |
| Name | Type | Description |
|---|---|---|
| SAR446959 | DRUG | Pharmaceutical form:solution for injection-Route of administration:Intra-articular injection |
| Placebo | DRUG | Pharmaceutical form:solution for injection-Route of administration:Intra-articular injection |
Inclusion Criteria: Participants must have a diagnosis of primary knee osteoarthritis, based on the American College of Rheumatology Clinical criteria using history and physical examination in the index knee * Participants must have index knee OA symptoms since at least 6 months before screening. *...