A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants (NCT07146750) | Clinical Trial Compass
CompletedPhase 1
A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
United States212 participantsStarted 2025-08-25
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 pa…
What they're measuring
1
PK parameter: Cmax
Timeframe: From Day 1 up to End of study (approximately 24 weeks)
2
Pharmacokinetic (PK) profile: AUC last
Timeframe: From Day 1 up to End of study (approximately 24 weeks)
3
Pharmacokinetic (PK) profile: AUC
Timeframe: From Day 1 up to End of study (approximately 24 weeks)