Clinical Trial

A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

Completed Phase 1
View on ClinicalTrials.gov →
Summary
This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-08-21; most recent amendment 2026-04-15.
Status change: Active, Not Recruiting → Completed 2026-04-15
Status change: Recruiting → Active, Not Recruiting 2025-12-04
Status change: Not Yet Recruiting → Recruiting 2025-09-18
Trial Details
NCT Number NCT07146750
Lead Sponsor Sanofi
Conditions Healthy Volunteers
Enrollment 212 participants
Start Date 2025-08-25
Primary Completion 2026-04-08 (estimated)
Study Completion 2026-04-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-20