NCT06704932

A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee

A Double-blind, Placebo Controlled First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intra-articular Doses of SAR446959, in Participants With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, participant- and Investigator-blinded Phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending single intra-articular doses of SAR446959 in female and male participants with osteoarthritis of the knee 45 to 65 years of age. The anticipated study duration for each participant is approximately 28 weeks including the following study periods: * Screening Period: from Day -28 to Day ˗2. * Institutionalization Period: from Day -1 to Day 3 (dosing on Day 1). * End-of-Study: Day 85 ±5 days * Post-treatment Observation Period: from Day 1 to Day 85 ±5 days after SAR446959 or Placebo injection (including 8 visits). * Follow-up Period: from the day after End-Of-Study Visit to Day 169 ±5 days (including 2 follow-up phone calls and 1 follow-up visit).

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	SAR446959	Pharmaceutical form:solution for injection-Route of administration:Intra-articular injection
DRUG	Placebo	Pharmaceutical form:solution for injection-Route of administration:Intra-articular injection

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-12-18
• Completion: 2025-12-18
• First posted: 2024-11-26
• Last updated: 2026-01-12

Locations

1 site across 1 country: Germany