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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Combination product: SAR445229

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
• Certified as healthy by a comprehensive clinical assessment [detailed medical history and complete physical examination including neurological exam (at screening and D1), skin, and mucous membranes].
• Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.

Exclusion Criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
• Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
• Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
• History of solid organ (including corneal transplant) or stem cell transplant.
• Any pre-planned major elective surgery known about at baseline visit that in the Investigator's opinion would impede participation in the study.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
• Blood donation, any volume, within 2 months before inclusion.
• Any nicotine use within 4 weeks before study inclusion. Regular smoking more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking or using nicotine for duration of the study.
• If female, pregnancy (defined as positive beta human chorionic gonadotropin [β-HCG] blood test), breast feeding.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS).	Combination product: SAR445229; Single dose; Other Names: Amlitelimab
Experimental: Group 2; Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP).	Combination product: SAR445229; Single dose; Other Names: Amlitelimab
Active Comparator: Group 3; Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS.	Combination product: SAR445229; Single dose; Other Names: Amlitelimab
Experimental: Group 4; Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP.	Combination product: SAR445229; Single dose; Other Names: Amlitelimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter: Cmax	Maximum serum concentration observed.	From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUC last	Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.	From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUC	Area under the serum concentration versus time curve extrapolated to infinity.	From Day 1 up to End of study (approximately 24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale score for pain with subcutaneous administration	VAS (visual analog scale) is used to evaluate pain at the treatment injection site. In a range between 0 to 10 where 10 is the worst pain.	Day 1
PK parameter: Tmax	Time to reach Cmax.	From Day 1 up to End of study (approximately 24 weeks)
PK parameter: t1/2z	Terminal half-life associated with the terminal slope (λz) determined	From Day 1 up to End of study (approximately 24 weeks)
PK parameter: CL/F	Apparent total body clearance after a single subcutaneous administration of a drug from the serum.	From Day 1 up to End of study (approximately 24 weeks)
PK parameter: Vz/F	Apparent volume of distribution during the terminal (λz) phase.	From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUCext	Percentage of extrapolated part of AUC.	From Day 1 up to End of study (approximately 24 weeks)
Percentage of participants who experienced TEAEs including ISRs, TESAEs, and/or TEAESIs	TEAEs (Treatment-Emergent Adverse Events) including ISRs (local tolerability assessment), TESAEs (Treatment-Emergent Serious Adverse Events), and/or TEAESIs (Treatment Emergent Adverse Event of Special Interest).	Up to end of study (approximately 24 weeks)
Percentage of participants with potentially clinically significant abnormalities	Clinically significant abnormalities including Clinical laboratory evaluations, Vital signs, electrocardiogram (ECG).	Up to end of study (approximately 24 weeks)
Incidence of participants with ADA (antidrug antibody) against amlitelimab.		Up to end of study (approximately 24 weeks)

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• BEQ19340 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Actual): April 8, 2026
• Study Completion (Actual): April 8, 2026

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: August 21, 2025
• First Posted (Actual): August 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BEQ19340; U1111-1318-3393 (Registry Identifier: ICTRP)

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