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TERMINATED
NCT06067425
PHASE2

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a Phase 2, open-label, multicenter, study to evaluate safety, tolerability and efficacy of SAR442501 in children from birth up to 12 years of age with Achondroplasia.

Official title: A Phase 2, Open-label, Multi-center, 2-stage Sequential Cohort, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Subcutaneous SAR442501 in Pediatric Participants With Achondroplasia

Key Details

Gender

All

Age Range

0 Days - 12 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2023-10-10

Completion Date

2025-02-12

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DRUG

SAR442501

Solution for injection; Subcutaneous injection

Locations (9)

Investigational Site Number : 0360001

Parkville, Victoria, Australia

Investigational Site Number : 1560002

Shanghai, China

Investigational Site Number : 1560001

Wuhan, China

Investigational Site Number : 3800002

Milan, Lombardy, Italy

Investigational Site Number : 3800001

Rome, Roma, Italy

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240002

Vitoria-Gasteiz, Basque Country, Spain

Investigational Site Number : 7240001

Esplugues de Llobregat, Catalunya [Cataluña], Spain