Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT06114238
- Lead Sponsor
- Sanofi
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
• Having given written informed consent prior to undertaking any study-related procedure.
Participants are excluded from the study if any of the following criteria apply:
• Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Itepekimab PFS Itepekimab administered via PFS Cohort 1 Itepekimab AI Itepekimab administered via AI
- Primary Outcome Measures
Name Time Method Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax Baseline up to EOS (approximately Day 141) Maximum plasma concentration of itepekimab
Assessment of PK parameter of itepekimab: AUClast Baseline up to EOS (approximately Day 141) AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Assessment of PK parameter of itepekimab: AUC Baseline up to EOS (approximately Day 141) AUC: Area under the plasma concentration versus time curve extrapolated to infinity
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter of itepekimab: CL/F Baseline up to EOS (approximately Day 141) Apparent total body clearance of a drug from the serum
Assessment of PK parameter of itepekimab: AUC0-28days Baseline up to Day 28 Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to 28 days
Assessment of PK parameter of itepekimab: t1/2 Baseline up to EOS (approximately Day 141) Terminal half-life associated with the terminal slope (λz)
Assessment of PK parameter of itepekimab: Vss/F Baseline up to EOS (approximately Day 141) Apparent Volume of Distribution at the steady state
Assessment of PK parameter of itepekimab: tmax Baseline up to EOS (approximately Day 141) Time to reach Cmax of itepekimab
Incidence of treatment-emergent anti-itepekimab antibodies responses Baseline up to EOS (approximately Day 141) Number of participants with Adverse Events (including injection site reactions), Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI) Baseline up to EOS (approximately Day 141)
Trial Locations
- Locations (1)
Clinical Pharmacology of Miami Site Number : 8400001
🇺🇸Miami, Florida, United States