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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia
Sponsor: Sanofi
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
Conditions
Interventions
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