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

NCT06114238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-09-19

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Itepekimab AI

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

DRUG

Itepekimab PFS

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-03-08
Completion
2022-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114238 on ClinicalTrials.gov