A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
32actual
Sites
1
Country
Germany
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-20 | actual | When the study began enrolling |
| Primary completion | 2025-12-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-18 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Osteoarthritis
Interventions
- Drug: SAR446959
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with adverse events (AEs)/treatment emergent adverse events (TEAEs) including injection site reactions
measured Day 1 up to the end-of-study visit (Day 85)
Number of participants with potentially clinically significant abnormalities (PCSAs)
measured Day 1 up to the end-of-study visit (Day 85)
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