CompletedNCT07177066Updated Aug 5, 2026

A Study of EDG-15400 in Healthy Adults

A Phase 1 interventional study of EDG-15400 and Placebo in Healthy Adults, sponsored by Edgewise Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Edgewise Therapeutics, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 84
Allocation: Randomized
Ages: 18 Years to 59 Years
Sex: All

Study summary

The purposes of this Phase 1 study of EDG-15400 are to:

Learn about the safety of EDG-15400 after single and multiple doses in healthy adults
Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults
Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults
Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults
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 studied

Healthy Adults

Who can participate

Ages eligible: 18 Years to 59 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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 criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 84 participants (actual)

Study arms

Experimental
Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose
Single oral ascending dose in fasted healthy adults
Drug: EDG-15400 · Drug: Placebo
Experimental
Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses
Multiple oral ascending doses once daily in fasted healthy adults
Drug: EDG-15400 · Drug: Placebo
Experimental
Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability
Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation
Drug: EDG-15400

Interventions

DrugEDG-15400
EDG-15400 is administered orally
DrugPlacebo
Placebo is administered orally

What researchers measure

Primary outcomes

Safety: incidence of treatment-emergent adverse events
To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults
Time frame: Up to 45 days of monitoring

Secondary outcomes

Determination of Tmax
Time to maximum concentration (Tmax)
Time frame: Up to 38 days
Determination of Cmax
Maximum observed concentration (Cmax)
Time frame: Up to 38 days
Determination of AUC
Area under the concentration-time curve (AUC)
Time frame: Up to 38 days
Determination of t1/2
Elimination half-life (t1/2)
Time frame: Up to 38 days
Determination of V/F
Apparent volume of distribution after oral administration (V/F)
Time frame: Up to 38 days
Determination of CL/F
Apparent clearance of drug after oral administration (CL/F)
Time frame: Up to 38 days
Determination of CLr
Renal clearance (CLr)
Time frame: Up to 38 days

Study locations

1 site

Celerion, Inc.
Tempe, Arizona 85283, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07177066
Lead sponsor: Edgewise Therapeutics, Inc.
Responsible party: Sponsor
First posted: Sep 16, 2025
Start date: Aug 20, 2025
Primary completion: Apr 29, 2026
Completion: Apr 29, 2026
Last update: Aug 5, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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