RecruitingPhase 1NCT07177066

A Study of EDG-15400 in Healthy Adults

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Healthy Adults

Sponsor

Edgewise Therapeutics, Inc.

Enrollment

108 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Adults

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 59 Years

Inclusion Criteria4

Willing and able to give informed consent and follow all study procedures and requirements.
Healthy male or nonpregnant female, ages ≥18 to <60 years.
Body mass index (BMI) ≥18.5 to <35 kg/m2; weight ≥55 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) ≤450 ms.

Exclusion Criteria9

Evidence of clinically significant abnormalities or disease.
Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing.
Donation or loss of > 1 unit (450 mL) of blood ≤ 1 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.