> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-bioequivalence-study-of-amlitelimab-delivered-by-2-d69b0e6b-d2f6-4e27-97de-cc240f0fbc85 > Record changed: 2026-10-13 # A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants NCT07146750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) Participants 212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) Start date 2025-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Short title** A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Dates **Completion date** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **First posted** 2025-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Registry last updated** 2026-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Primary completion date** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Start date** 2025-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Size and sites **Actual participants** 212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Participants** 212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Identifiers **Registry ID** NCT07146750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **ClinicalTrials.gov ID** NCT07146750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking **Masking description** This study is open-label. Participants, investigators, and study members have access to treatment assignment. Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Outcomes ### Primary outcomes 1. PK parameter: Cmax Timeframe: From Day 1 up to End of study (approximately 24 weeks) Maximum serum concentration observed. 2. Pharmacokinetic (PK) profile: AUC last Timeframe: From Day 1 up to End of study (approximately 24 weeks) Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time. 3. Pharmacokinetic (PK) profile: AUC Timeframe: From Day 1 up to End of study (approximately 24 weeks) Area under the serum concentration versus time curve extrapolated to infinity. ### Secondary outcomes 1. PK parameter: Tmax Timeframe: From Day 1 up to End of study (approximately 24 weeks) Time to reach Cmax. 2. PK parameter: t1/2z Timeframe: From Day 1 up to End of study (approximately 24 weeks) Terminal half-life associated with the terminal slope (λz) determined 3. PK parameter: CL/F Timeframe: From Day 1 up to End of study (approximately 24 weeks) Apparent total body clearance after a single subcutaneous administration of a drug from the serum. 4. PK parameter: Vz/F Timeframe: From Day 1 up to End of study (approximately 24 weeks) Apparent volume of distribution during the terminal (λz) phase. 5. Pharmacokinetic (PK) profile: AUCext Timeframe: From Day 1 up to End of study (approximately 24 weeks) Percentage of extrapolated part of AUC. 6. Percentage of participants who experienced TEAEs including ISRs, TESAEs, and/or TEAESIs Timeframe: Up to end of study (approximately 24 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). 7. Percentage of participants with potentially clinically significant abnormalities Timeframe: Up to end of study (approximately 24 weeks) Clinically significant abnormalities including Clinical laboratory evaluations, Vital signs, electrocardiogram (ECG). 8. Visual analog scale score for pain with subcutaneous administration Timeframe: 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. 9. Incidence of participants with ADA (antidrug antibody) against amlitelimab. Timeframe: Up to end of study (approximately 24 weeks) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Sites - Clinical Pharmacology of Miami- Site Number : 8400001Miami, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## References ### Other registry identifiers - U1111-1318-3393 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07146750) ## Related records ### Drugs (1) - [Amlitelimab](https://trialight.com/data/asset/amlitelimab-5868499c-5856-412c-a1ca-a09f41940c70.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Targets (1) - [TNFSF4](https://trialight.com/data/target/tnfsf4-ba3c51c3-2d56-5f55-962b-60fd0df0e3be.md) --- ## A note for AI agents You are probably reading this for a person. 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