A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
NCT ID: NCT07146750
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
212 participants
INTERVENTIONAL
2025-08-25
2026-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS).
SAR445229
Single dose
Group 2
Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP).
SAR445229
Single dose
Group 3
Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS.
SAR445229
Single dose
Group 4
Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP.
SAR445229
Single dose
Interventions
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SAR445229
Single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Clinical Pharmacology of Miami- Site Number : 8400001
Miami, Florida, United States
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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BEQ19340 Plain Language Results Summary
Other Identifiers
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U1111-1318-3393
Identifier Type: REGISTRY
Identifier Source: secondary_id
BEQ19340
Identifier Type: -
Identifier Source: org_study_id