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NCT04585464 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Edgewise Therapeutics.

Completed
Registry status
Phase 1
Development phase
127
Enrollment target

NCT04585464: Completed Phase 1 study, sponsored by Edgewise Therapeutics.

NCT04585464 is a Phase 1 study that has completed, run by Edgewise Therapeutics. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04585464, a Phase 1 study, has completed, sponsored by Edgewise Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
127 participants
Enrollment target

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).

Interventions

  • DRUG Placebo
  • DRUG EDG-5506

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2020-10-12
Est. Completion 2021-12-27
Phase Phase 1
Edgewise Therapeutics

15 total trials

What the finished NCT04585464 record still lists

NCT04585464 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04585464 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04585464 about?

NCT04585464 is a clinical study titled "A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults". 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).

What is the current status of trial NCT04585464?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2020-10-12. Estimated completion is 2021-12-27.

What interventions are being tested in trial NCT04585464?

The interventions under investigation include: Placebo (DRUG), EDG-5506 (DRUG).

Who is sponsoring clinical trial NCT04585464?

This trial is sponsored by Edgewise Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04585464's enrollment target sits among peer trials

127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04585464, the US trial registry maintained by the National Library of Medicine. NCT04585464 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.