Trials / Completed
CompletedNCT04585464
A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults
A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and PK of EDG-5506 in Adult Healthy Volunteers and Adults With Becker Muscular Dystrophy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Edgewise Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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).
Detailed description
Enrolled participants in this study will receive a single oral dose or multiple oral doses of EDG-5506 or a placebo. Blood and urine samples will be collected to measure how EDG-5506 is processed by the body and how the body responds when exposed to EDG-5506. Participants in the single ascending dose part of the study will remain in the clinic for 7 days with a 42-day follow-up period. Participants in the multiple ascending dose part of the study will remain in the clinic for 16 days with a 13-day follow-up period. Safety, tolerability, and pharmacokinetics of EDG-5506 will be assessed in healthy volunteers prior to enrolling participants with Becker muscular dystrophy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-10-12
- Primary completion
- 2021-11-15
- Completion
- 2021-12-27
- First posted
- 2020-10-14
- Last updated
- 2022-06-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04585464. Inclusion in this directory is not an endorsement.