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ACTIVE NOT RECRUITING
NCT07146750
PHASE1

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

Sponsor: Sanofi

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.

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

Interventions

COMBINATION_PRODUCT

SAR445229

Single dose

Locations (1)

Clinical Pharmacology of Miami- Site Number : 8400001

Miami, Florida, United States