EDG-5506 for Healthy Volunteers

Overseen By Edgewise Therapeutics, Inc.

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Edgewise Therapeutics, Inc.

Disqualifiers: Metabolic, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes a new drug called EDG-5506, an experimental treatment. Researchers seek to determine how the drug is absorbed, metabolized, and excreted when taken orally, and to compare its bioavailability between oral and intravenous methods. The study seeks healthy men who feel in good shape and have not experienced major health issues. Those who fit this profile might be suitable for the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy volunteers, it is likely that participants should not be on any regular medications.

Is there any evidence suggesting that EDG-5506 is likely to be safe for humans?

Research has shown that EDG-5506 is generally safe for people. In earlier studies, dizziness and sleepiness were the most common side effects. These mild effects typically occurred at the start of treatment. Importantly, no serious side effects were reported, suggesting the treatment is relatively safe for healthy individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care, which involves various treatments that may not efficiently target muscle health, EDG-5506 is designed to specifically modulate muscle function. Researchers are excited about EDG-5506 because it works by stabilizing muscle fibers and potentially reducing muscle damage caused by daily activities. This novel approach could lead to better outcomes for conditions affecting muscle integrity and strength, offering a promising alternative to current therapies that primarily focus on symptom management rather than the underlying muscle issues.

What evidence suggests that EDG-5506 could be effective?

Research shows that EDG-5506, an experimental drug, is being tested for its potential to treat muscle diseases like Becker muscular dystrophy. Studies indicate that EDG-5506 specifically affects the speed of muscle fiber contraction, which might improve muscle function. Early findings suggest that the drug is well-absorbed and processed by the body, with positive results observed in previous research. Notably, a daily dose of 10 mg reached promising levels in the body for further study. While more information is needed, these early results offer hope for its future use in muscle conditions. ^{2 5 6 7 8}

Who Is on the Research Team?

Sam Collins, MBBS, PhD

Principal Investigator

Edgewise Therapeutics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Body mass index between 18.0 and 32.0 kg/m2 and total body weight greater than or equal to 50 kg

Good health determined by medical history, electrocardiogram, vital signs measurements, and clinical laboratory evaluations

Exclusion Criteria

Participation in more than 3 radiolabeled drug studies in the last 12 months

Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in

You have a history of a significant medical condition or currently have symptoms of a medical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4-6 weeks

Part A - Treatment

Evaluation of absorption, metabolism, excretion, and pharmacokinetics of a single oral dose of radiolabeled EDG-5506

30-36 days

Confined to study site

Part B - Treatment

Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506

8 days

Confined to study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDG-5506

How Is the Trial Designed?

Group I: Part B - aBA Experimental Treatment 2 Interventions

Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers

Group II: Part A - AME Experimental Treatment 1 Intervention

Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers

Who Is Running the Clinical Trial?

Edgewise Therapeutics, Inc.

Lead Sponsor

Trials

13

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05160415

NCT05160415 | A Study of EDG-5506 in Adult Males With ... The ARCH study was an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in ...

2. withpower.com withpower.com/trial/phase-1-nervous-system-diseases-2023-d36eb

Absorption, Metabolism, Excretion and Absolute ... Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506. 8 days. Confined to study site.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40452637/

A Phase 1, Double-Blind, Placebo-Controlled Trial of ... Sevasemten (EDG-5506) is an orally administered, investigational small molecule that selectively modulates fast muscle fiber contraction by inhibiting fast ...

4. edgewisetx.com edgewisetx.com/wp-content/uploads/2024/08/WMS_Symposium_Donovan_ARCH_6_mos_FINAL_SLIDES_for_pdf.pdf

EDG-5506 pharmacokinetics (PK) of EDG-5506 in adults with Becker muscular dystrophy ... Source: Data on file for month 4 (n=10) or 6 (n=2) as available. Baseline.

5. clinicaltrials.eu clinicaltrials.eu/inn/edg-5506/

Edg-5506 – Application in Therapy and Current Clinical ... EDG-5506 is an investigational drug currently being studied for its potential to treat various forms of muscular dystrophy, particularly Becker muscular ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000206199

Effects of EDG-5506, a Fast Myosin Modulator, on Function ... Most common adverse events were dizziness (n=4), somnolence (n=3) and COVID-19 (n=3). Dizziness/somnolence were typically at dose initiation and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960896622004424

P.124 EDG-5506 targets fast skeletal myosin and reduces ... EDG-5506 was well-tolerated at all doses in healthy adults. Most common adverse events were somnolence and dizziness, which were mild and transient.

8. institut-myologie.org institut-myologie.org/en/2025/07/17/edg-5506-sevasemten-stabilises-functional-scores-in-beckers-myopathy/

EDG-5506 (sevasemten) stabilises functional scores in ... ... side-effects, the most frequent being dizziness and drowsiness. In BMD patients, creatine kinase (CK) levels fell by an average of 70%, fast ...