Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe

Part of paid clinical trials in Miami, Florida.

Sponsor: Sanofi
Study ID: NCT06114238
Phase: PHASE1
Status: Completed

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Accepted

Interventions

Itepekimab AI — DRUG
Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI
Itepekimab PFS — DRUG
Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS

Study Details

This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP). Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) \>18.5 and ≤30 kg/m2. Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups: * Itepekimab administered via AI (test) * Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (\<70 kg, ≥70 to \<80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm). Study duration for each participant is up to approximately 162 days, including: * Screening period: up to 21 days * Institutionalization: 2 days including 1 treatment day (Day 1) * Follow-up period: 140 days (±5 days) * End of study (EOS): Day 141 (± 5 days)