NCT05796479

A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

A 2-part, Open Label, Phase 1 Study to Investigate the Pharmacokinetics, Safety and Tolerability of Two Different Amlitelimab Drug Products After Administration of a Single Subcutaneous Dose in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC) dose in healthy adult participants. Study details include: The study duration for a participant will be approximately 17 weeks. The study includes a screening period of up to 28 days, a 4-day institutionalization period, and a follow up period for approximately 89 days (9 visits).

Detailed description

The study duration for a participant will be approximately 17 weeks

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Amlitelimab DP1	Injection solution 1 Subcutaneous
DRUG	Amlitelimab DP2	Injection solution 2 Subcutaneous

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2023-04-03
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study