Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT06704932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: