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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Itepekimab PFS; Drug: Itepekimab AI

Study type: Interventional

Funder types: Industry

Identifiers

NCT06114238

PKM16966

U1111-1260-3853 (Registry Identifier)

Details and patient eligibility

About

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)

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Itepekimab administered via AI

Treatment:

Drug: Itepekimab AI

Cohort 2

Active Comparator group

Description:

Itepekimab administered via PFS

Treatment:

Drug: Itepekimab PFS