MedTrace Logo

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

NCT06704932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-12-18
Completion
2025-12-18

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704932 on ClinicalTrials.gov