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New drug EDG-15400 tested in healthy people for first time

NCT ID NCT07177066

Knowledge-focused Sponsor: Edgewise Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This early-stage study is testing a new oral drug called EDG-15400 in 108 healthy adults aged 18 to 59. The main goal is to check if the drug is safe and how well it is tolerated, both after a single dose and after multiple doses. Researchers will also measure how much of the drug gets into the blood and urine, and whether food or the form of the drug (tablet vs. liquid) changes those levels. This is a Phase 1 trial, so it is focused on safety and drug behavior, not on treating any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EDG-15400 (oral drug)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

84 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 59 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to give informed consent and follow all study procedures and requirements. 2. Healthy male or nonpregnant female, ages ≥18 to \<60 years. 3. Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening. 4. 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 Criteria: 1. Evidence of clinically significant abnormalities or disease. 2. 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. 3. Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing. 4. Females: nursing, lactating, or pregnant. 5. Females: breast implants. 6. Use of nicotine-containing products in the last 6 months prior to dosing. 7. History of substance abuse or dependency or history of recreational drug use within the last 2 years. 8. Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening. 9. Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission. Additional protocol defined inclusion/exclusion criteria may apply.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy adults

Contacts and locations

Locations

  • Celerion, Inc.

    Tempe, Arizona, 85283, United States

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