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

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT07146750
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study Start: 2025-08-25
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2026-03-25
• Study Completion: 2026-03-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

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).
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PK parameter: Cmax	From Day 1 up to End of study (approximately 19 weeks)	Maximum serum concentration observed.
Pharmacokinetic (PK) profile: AUC last	From Day 1 up to End of study (approximately 19 weeks)	Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Pharmacokinetic (PK) profile: AUC	From Day 1 up to End of study (approximately 19 weeks)	Area under the serum concentration versus time curve extrapolated to infinity.

Secondary Outcome Measures

Name	Time	Method
PK parameter: Tmax	From Day 1 up to End of study (approximately 19 weeks)	Time to reach Cmax.
PK parameter: t1/2z	From Day 1 up to End of study (approximately 19 weeks)	Terminal half-life associated with the terminal slope (λz) determined
PK parameter: CL/F	From Day 1 up to End of study (approximately 19 weeks)	Apparent total body clearance after a single subcutaneous administration of a drug from the serum.
PK parameter: Vz/F	From Day 1 up to End of study (approximately 19 weeks)	Apparent volume of distribution during the terminal (λz) phase.
Pharmacokinetic (PK) profile: AUCext	From Day 1 up to End of study (approximately 19 weeks)	Percentage of extrapolated part of AUC.
Percentage of participants who experienced TEAEs including ISRs, TESAEs, and/or TEAESIs	Up to end of study (approximately 19 weeks)	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).
Percentage of participants with potentially clinically significant abnormalities	Up to end of study (approximately 19 weeks)	Clinically significant abnormalities including Clinical laboratory evaluations, Vital signs, electrocardiogram (ECG).
Visual analog scale score for pain with subcutaneous administration	Day 1	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.
Incidence of participants with ADA (antidrug antibody) against amlitelimab.	Up to end of study (approximately 19 weeks)