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A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
Sponsor: Sanofi
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.
Official title: An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2025-08-25
Completion Date
2026-04-08
Last Updated
2025-12-05
Healthy Volunteers
Yes
Conditions
Interventions
SAR445229
Single dose
Locations (1)
Clinical Pharmacology of Miami- Site Number : 8400001
Miami, Florida, United States