Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT06704932
Brief 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).
Study:
NCT06704932
Study Brief:
Protocol Section:
NCT06704932