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EDG-7500 for Healthy Adults

ET
Overseen ByEdgewise Therapeutics, Inc.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Edgewise Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EDG-7500 to observe its behavior in the blood after single and multiple doses. The study will also assess the treatment's safety for participants. It specifically targets healthy Japanese and Caucasian adults without major health issues that could affect drug absorption or metabolism. Participants must not have used tobacco or nicotine products in the past six months. 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 is for healthy adults, it might imply that participants should not be on any regular medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that EDG-7500 is likely to be safe for humans?

Research has shown that EDG-7500 demonstrates promising safety results from earlier studies. Tests with both healthy individuals and those with hypertrophic cardiomyopathy (HCM) indicate that EDG-7500 was generally well-tolerated. Most side effects were mild and similar to those seen with a placebo, a harmless pill used for comparison. The treatment did not significantly alter the heart's pumping efficiency, as measured by the left ventricle ejection fraction (LVEF). This suggests that EDG-7500 might be safe for humans, though ongoing studies will provide further confirmation.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about EDG-7500 because it potentially offers a novel approach to treatment, differing from typical medications that often focus on symptom management. Unlike current options, EDG-7500 might work by targeting a new pathway or mechanism, possibly leading to more effective outcomes. This could mean improved efficacy and quicker results, offering a significant advantage over existing therapies. Additionally, the investigation across diverse populations, such as Japanese and Caucasian cohorts, suggests a broad potential applicability, enhancing its appeal.

What evidence suggests that EDG-7500 might be effective for healthy adults?

Research has shown that EDG-7500 could be a promising treatment for hypertrophic cardiomyopathy, a condition where the heart muscle thickens excessively. In studies, EDG-7500 relieved symptoms without major side effects on heart function. It helps the heart muscle relax more effectively. This trial will test EDG-7500 in healthy adults, as various trials have demonstrated its safety in this group. While more research is needed, early results offer hope for those with heart muscle problems.23678

Are You a Good Fit for This Trial?

This trial is for healthy Japanese or Caucasian adults aged 18-55, with normal heart rate and blood pressure, a BMI between 18 and 35, good kidney function, and no major health issues. Participants must agree to use contraception during the study.

Inclusion Criteria

* Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and \<140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
I am between 18 and 55 years old.
I am willing to use birth control as required by the study.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single and multiple doses of EDG-7500 to evaluate pharmacokinetics and safety

13 days
Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 days
1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • EDG-7500

Trial Overview

The study tests different doses of a new drug called EDG-7500 in healthy adults to see how much of it gets into the blood after single and multiple doses. It also compares results between Japanese and Caucasian participants.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Cohort 3 - Healthy Caucasian AdultsExperimental Treatment1 Intervention
Group II: Cohort 2 - Healthy Japanese AdultsExperimental Treatment1 Intervention
Group III: Cohort 1 - Healthy Japanese AdultsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Edgewise Therapeutics, Inc.

Lead Sponsor

Trials
13
Recruited
1,000+

Citations

Emerging Pharmacological and Invasive Therapies for ... - PMC

... EDG-7500 in adults with oHCM and non-obstructive HCM.56,57 Unpublished preliminary data from CIRRUS-HCM show promising results, with a ...

A Study to Evaluate EDG-7500 in People With Renal ...

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of ...

Edgewise Therapeutics Announces Completion of the EDG ...

Consistent with previous observations, no clinically significant changes in LVEF or reductions in LVEF to below 50% were observed, with EDG-7500 ...

EDG-7500 - Cardiac Diastolic Dysfunction

We are developing EDG-7500, a selective cardiac sarcomere modulator, with the aim to slow early contraction velocity and address impaired cardiac relaxation ...

Novel Cardiac Sarcomere Modulator, EDG-7500, in ...

EDG-7500, a first-in-class cardiac sarcomere modulator, demonstrates favorable tolerability, safety, and pharmacokinetics in healthy adults and ...

EDG-7500, A First-in-Class Cardiac Sarcomere Modulator ...

EDG-7500 was well tolerated; adverse events were generally mild and comparable in frequency to those seen with placebo. The observed half-life supports once- ...

EDG-7500 for Healthy Adults · Info for Participants

Participants receive single and multiple doses of EDG-7500 to evaluate pharmacokinetics and safety. 13 days. Daily visits for dosing and monitoring. Follow-up.

A Study of EDG-7500 in Adults With Hypertrophic ...

Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening (BMI ≥ 18 to < 40 kg/m2 is permitted for participants < 50 years).