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

Study on Comparing Medication Effects Using Different Devices

Recruiting
18 years - 55 years
All
Phase 1
212 participants needed
1 Location

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy Volunteers
  • Age: 18 years - 55 years
  • Gender: All

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.

This study investigates the bioequivalence, which means comparing the effects, of an investigational medication delivered by two different devices in healthy adults. The purpose is to see if the medication works the same way when given through these devices. Participants will receive different doses of the medication, which is given under the skin, to check its safety and how well it is tolerated.

Participants in this study will be randomly assigned to one of four study arms. Each arm will receive a single dose of the investigational medication using one of the two devices. The study will involve medical assessments and observations to ensure the safety and health of the participants.

  • Who can participate: Healthy adults aged 18 to 55 years with a body weight of 50-100 kg for males and 40-90 kg for females are eligible. Participants must not have a history of significant health issues or recent surgeries, and must be non-smokers.
  • Study details: Participants will receive a single dose of the investigational medication through one of two devices. The study will involve medical assessments to monitor safety and effects.
Updated on 13 Nov 2025. Study ID: NCT07146750

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