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A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

NCT07146750 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-04-20

No results posted yet for this study

Summary

This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.

Conditions

  • Healthy Volunteers

Interventions

COMBINATION_PRODUCT

SAR445229

Single dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-04-08
Completion
2026-04-08
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 NCT07146750 on ClinicalTrials.gov