NCT06114238

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

A Phase 1, Single-center, Open-label, Randomized, Parallel Group, Single-dose Study to Compare the Pharmacokinetics of Subcutaneous Itepekimab Administered With an Autoinjector Versus Prefilled Syringe in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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)

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Itepekimab AI	Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI
DRUG	Itepekimab PFS	Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-03-08
• Completion: 2022-03-08
• First posted: 2023-11-02
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study