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

Sanofi

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Combination Product: SAR445229

Study type: Interventional

Funder types: Industry

Identifiers

NCT07146750

U1111-1318-3393 (Registry Identifier)

BEQ19340

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 4 patient groups

Group 1

Active Comparator group

Description:

Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS).

Treatment:

Combination Product: SAR445229

Group 2

Experimental group

Description:

Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP).

Treatment:

Combination Product: SAR445229

Group 3

Active Comparator group

Description:

Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS.

Treatment:

Combination Product: SAR445229

Group 4

Experimental group

Description:

Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP.

Treatment:

Combination Product: SAR445229