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

NCT07146750 | Completed Phase 1 FDA Drug

• 2 other identifiers: BEQ19340U1111-1318-3393
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• PK parameter: Tmax

  From Day 1 up to End of study (approximately 24 weeks)

• PK parameter: t1/2z

  From Day 1 up to End of study (approximately 24 weeks)

• PK parameter: CL/F

  From Day 1 up to End of study (approximately 24 weeks)

• PK parameter: Vz/F

  From Day 1 up to End of study (approximately 24 weeks)

• Pharmacokinetic (PK) profile: AUCext

  From Day 1 up to End of study (approximately 24 weeks)

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS).

Combination Product: SAR445229

Group 2

EXPERIMENTAL

Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP).

Combination Product: SAR445229

Group 3

ACTIVE COMPARATOR

Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS.

Combination Product: SAR445229

Group 4

EXPERIMENTAL

Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP.

Combination Product: SAR445229

Interventions

SAR445229 COMBINATION_PRODUCT

Single dose

Also known as: Amlitelimab

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Clinical Pharmacology of Miami- Site Number : 8400001

Miami, Florida, 33014, United States

Location

Related Links

• BEQ19340 Plain Language Results Summary

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label. Participants, investigators, and study members have access to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1:1:1 ratio.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: August 25, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)