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SAR446959

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

Ensayo de Sanofi en Artrosis.

Más ensayos de: Artrosis.

Fase

Fase 1

Estado

Completado

Participantes

32

previstos

Centros

1

Fin del objetivo primario

dic 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en nov 2024.

Qué mide

Number of participants with adverse events (AEs)/treatment emergent adverse events (TEAEs) including injection site reactions (Day 1 up to the end-of-study visit (Day 85)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06704932), actualizada en ene 2026.