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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2022-03-08

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)

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Itepekimab administered via AI

Group Type EXPERIMENTAL

Itepekimab AI

Intervention Type DRUG

Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI

Cohort 2

Itepekimab administered via PFS

Group Type ACTIVE_COMPARATOR

Itepekimab PFS

Intervention Type DRUG

Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS

Interventions

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Itepekimab AI

Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI

Intervention Type DRUG

Itepekimab PFS

Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS

Intervention Type DRUG

Other Intervention Names

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SAR440340/REGN3500 SAR440340/REGN3500

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes