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

Part of paid clinical trials in Hialeah, Florida.

Sponsor
Sanofi
Study ID
NCT05796479
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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).

Key Dates

First listed
Apr 3, 2023
Start date
Apr 28, 2022
Status verified
Sep 2025
Primary completion
May 22, 2023
Completion
May 22, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1 (Part1)
    Participants will receive a single SC dose of amlitelimab DP1 on Day 1.
  • Experimental: Group 2 (Part 2)
    Participants will receive a single SC dose of amlitelimab DP1 on Day 1.
  • Experimental: Group 3 (Part 2)
    Participants will receive a single SC dose of amlitelimab DP2 on Day 1.

Primary Outcome Measure

Part 1: Maximum Plasma concentration observed (Cmax ) [ Time Frame: From Day1 up to Day92 (end of study [EOS]) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami-Site Number: 8400001HialeahFlorida33014-

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By research site
Clinical Pharmacology of Miami· Hialeah, FL

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