A Study of EDG-15400 in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT07177066

Run by

Edgewise Therapeutics, Inc.

People needed

84

Starts

2025-08-20

Expected to finish

2026-04-29

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Additional protocol defined inclusion/exclusion criteria may apply.

Where it is running

• Celerion, Inc. — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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