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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Amlitelimab DP1; Drug: Amlitelimab DP2

Detailed Description

The study duration for a participant will be approximately 17 weeks

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33014
      • Clinical Pharmacology of Miami-Site Number: 8400001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, and laboratory tests
• Body weight within 55 to 100 kg and body mass index (BMI) within the range 18-30 kg/m2 (inclusive)
• Male or female of childbearing potential are required to either practice true abstinence consistent with their preferred and usual lifestyle or use highly effective contraceptive methods for the entire duration of the treatment until 4 months after the investigational medicinal product (IMP) dosing.

Exclusion Criteria:

• Any history or presence of clinically relevant immunologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, unless the investigator considers an abnormality to be not clinically significant.
• Participants with a history of helminthic infection or invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, aspergillosis, irrespective of resolution.
• Serious infections requiring hospitalization within 30 days prior to screening or any active infection requiring treatment during screening.
• Current or past diagnosis of malignancies within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).
• Presence or history of drug hypersensitivity or allergic disease diagnosed and treated by a physician.
• Evidence of active or latent tuberculosis (TB XE ' TB ' \f Abbreviation \t 'tuberculosis ' ) as documented by medical history and examination; TB testing via a positive (not indeterminate) QuantiFERON TB Gold test
• If female, pregnancy (defined as positive beta human chorionic gonadotropin [β-HCG] test), or lactating. - Received a live (attenuated) immunization within 12 weeks prior to inclusion or non-live immunization within 4 weeks prior to inclusion.
• Any medication, with the exception of hormonal contraception, within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, whichever is longer, and any biologics (antibody or its derivatives) given within 4 months before inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Part1); Participants will receive a single SC dose of amlitelimab DP1 on Day 1.	Drug: Amlitelimab DP1; Injection solution 1 Subcutaneous
Experimental: Group 2 (Part 2); Participants will receive a single SC dose of amlitelimab DP1 on Day 1.	Drug: Amlitelimab DP1; Injection solution 1 Subcutaneous
Experimental: Group 3 (Part 2); Participants will receive a single SC dose of amlitelimab DP2 on Day 1.	Drug: Amlitelimab DP2; Injection solution 2 Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Maximum Plasma concentration observed (Cmax )	Cmax after administration of a single SC dose of amlitelimab DP 1	From Day1 up to Day92 (end of study [EOS])
Part 1: Area under the curve from the time of dosing to the last measurable concentration (AUClast)	AUClast after administration of a single SC dose of amlitelimab DP 1	From Day1 up to Day92 (EOS)
Part 1: Area under the plasma concentration versus time curve extrapolated to infinity (AUC)	AUC after administration of a single SC dose of amlitelimab DP 1	From Day1 up to Day92 (EOS)
Part 2: Cmax of two different amlitelimab DPs (DP1 and DP2)	Cmax after administration of a single SC dose of amlitelimab DP 1 and DP2	From Day1 up to Day92 (EOS)
Part 2: AUClast of two different amlitelimab DPs (DP1 and DP2)	AUClast after administration of a single SC dose of amlitelimab DP1 and DP 2	From Day1 up to Day92 (EOS)
Part 2: AUC of two different amlitelimab DPs (DP1 and DP2)	AUC after administration of a single SC dose of amlitelimab DP1 and DP 2	From Day1 up to Day92 (EOS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Incidence of adverse events (AE)/treatment-emergent adverse events (TEAEs)	Incidence of AEs and TEAEs after administration of amlitelimab will be reported.	From the signing of the informed consent form (ICF) up to Day92 EOS visit

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• PKM17597 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PKM17597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No