MedTrace Logo

A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

NCT05796479 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC) dose in healthy adult participants.

Study details include:

The study duration for a participant will be approximately 17 weeks. The study includes a screening period of up to 28 days, a 4-day institutionalization period, and a follow up period for approximately 89 days (9 visits).

Conditions

  • Healthy Volunteers

Interventions

DRUG

Amlitelimab DP1

Injection solution 1 Subcutaneous

DRUG

Amlitelimab DP2

Injection solution 2 Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-05-22
Completion
2023-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05796479 on ClinicalTrials.gov