Actively Recruiting

Phase 1
Age: 18Years - 59Years
All Genders
Healthy Volunteers
NCT07177066

A Study of EDG-15400 in Healthy Adults

Led by Edgewise Therapeutics, Inc. · Updated on 2025-09-16

108

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purposes of this Phase 1 study of EDG-15400 are to: 1. Learn about the safety of EDG-15400 after single and multiple doses in healthy adults 2. Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults 3. Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults 4. Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.

CONDITIONS

Official Title

A Study of EDG-15400 in Healthy Adults

Who Can Participate

Age: 18Years - 59Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give informed consent and follow all study procedures and requirements.
  • Healthy male or nonpregnant female, ages 6518 to <60 years.
  • Body mass index (BMI) 6518.5 to <35 kg/m2; weight 6555 kg at Screening.
  • Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) 65450 ms.
Not Eligible

You will not qualify if you...

  • Evidence of clinically significant abnormalities or disease.
  • Unless permitted by protocol, use of any prescription medication 654 weeks or investigational medication 6512 weeks or 655 half-lives (whichever is longer) of dosing.
  • Use of any non-prescription medication or herbal/nutritional supplement 655 days prior to dosing.
  • Donation or loss of > 1 unit (450 mL) of blood 651 month prior to dosing.
  • Females: nursing, lactating, or pregnant.
  • Females: breast implants.
  • Use of nicotine-containing products in the last 6 months prior to dosing.
  • History of substance abuse or dependency or history of recreational drug use within the last 2 years.
  • Alcohol consumption > 14 drinks per week for males (7 for females) within 45 days of screening.
  • Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Additional protocol defined inclusion/exclusion criteria may apply.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Celerion, Inc.

Tempe, Arizona, United States, 85283

Actively Recruiting

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Research Team

C

Contact: Edgewise Therapeutics, Inc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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