Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
Status:
Completed
Trial end date:
2022-03-08
Target enrollment:
Participant gender:
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)