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A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy — ARCH  

Becker Muscular Dystrophy Clinical Trial

Official title:
A Phase 1b, Open-label Study of the Safety and Pharmacokinetics of EDG-5506 in Adults With Becker Muscular Dystrophy

Clinical Trial Summary

The ARCH study is an open-label, single-center, Phase 1b study of EDG-5506 to assess the safety and pharmacokinetics (PK) of EDG-5506 in adults with Becker muscular dystrophy (BMD). EDG-5506 is an investigational product intended to protect and improve function of dystrophic muscle fibers.

Clinical Trial Description

This open-label study will evaluate the safety, tolerability, and pharmacokinetics (PK) of EDG-5506 in participants with BMD who completed the first-in-human study, EDG-5506-001, as well as additional (treatment-naïve) participants from outside the EDG-5506-001 study to meet the target sample size. All participants will receive EDG-5506. On-site visits will occur approximately monthly for the first 12 months, followed by every 3 months to assess safety and measures of function. This study will have a 24 month treatment period, followed by a 4 week follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05160415
Study type Interventional
Source Edgewise Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 28, 2021
Completion date March 1, 2024
View Details
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