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A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults

NCT04585464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2022-06-28

No results posted yet for this study

Summary

EDG-5506 is an investigational product intended to protect and improve function of dystrophic muscle fibers. This Phase 1 study of EDG-5506 will assess the safety, tolerability, and pharmacokinetics (PK) and of EDG-5506 in adult healthy volunteers and in adults with Becker muscular dystrophy (BMD).

Conditions

  • Healthy Volunteer
  • Becker Muscular Dystrophy

Interventions

DRUG

EDG-5506

EDG-5506 is administered orally as a single dose or once daily

DRUG

Placebo

Placebo is administered orally as a single dose or once daily

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Edgewise Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2021-11-15
Completion
2021-12-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04585464 on ClinicalTrials.gov