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A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)

Duchenne Muscular Dystrophy (DMD) Clinical Trial

Official title:
A Randomized, Double Blind, Placebo-Controlled Phase 1b Study With Open-Label Extension to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Patients With Duchenne Muscular Dystrophy (DMD)

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367.

Clinical Trial Description

This study is comprised of a 4-week pre-treatment screening period, 24-week treatment period and 4-week post-treatment follow-up period. The 24-week treatment period consists of a 12-week double-blind (DB) part and 12-week open-label extension (OLE) part and each part includes a 2 week Low dose Period and a 10-week High-dose Period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04184882
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 1
Start date February 24, 2021
Completion date September 4, 2022
View Details
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