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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Itepekimab AI
* Drug: Itepekimab PFS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Itepekimab administered via AI | Drug: Itepekimab AI<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous AI<br>* Other names: SAR440340;|
| Active Comparator: Cohort 2<br>Itepekimab administered via PFS | Drug: Itepekimab PFS<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous PFS<br>* Other names: SAR440340;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax | Maximum plasma concentration of itepekimab | Baseline up to EOS (approximately Day 141) | 
| Assessment of PK parameter of itepekimab: AUClast | AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast | Baseline up to EOS (approximately Day 141) | 
| Assessment of PK parameter of itepekimab: AUC | AUC: Area under the plasma concentration versus time curve extrapolated to infinity | Baseline up to EOS (approximately Day 141) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of PK parameter of itepekimab: tmax | Time to reach Cmax of itepekimab | Baseline up to EOS (approximately Day 141) | 
| Assessment of PK parameter of itepekimab: AUC0-28days | Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to 28 days | Baseline up to Day 28 | 
| Assessment of PK parameter of itepekimab: t1/2 | Terminal half-life associated with the terminal slope (λz) | Baseline up to EOS (approximately Day 141) | 
| Assessment of PK parameter of itepekimab: CL/F | Apparent total body clearance of a drug from the serum | Baseline up to EOS (approximately Day 141) | 
| Assessment of PK parameter of itepekimab: Vss/F | Apparent Volume of Distribution at the steady state | Baseline up to EOS (approximately Day 141) | 
| 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) |