A Study of EDG-15400 in Healthy Adults

Not Applicable

Recruiting

• Conditions: Healthy Adults
• Interventions: Drug: EDG-15400; Drug: Placebo

• Registration Number: NCT07177066
• Lead Sponsor: Edgewise Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-20
• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2026-05
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety: incidence of treatment-emergent adverse events	Up to 25 days of monitoring	To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults

Secondary Outcome Measures

Name	Time	Method
Determination of Tmax	Up to 25 days	Time to maximum concentration (Tmax)
Determination of Cmax	Up to 25 days	Maximum observed concentration (Cmax)
Determination of AUC	Up to 25 days	Area under the concentration-time curve (AUC)
Determination of t1/2	Up to 25 days	Elimination half-life (t1/2)
Determination of V/F	Up to 25 days	Apparent volume of distribution after oral administration (V/F)
Determination of CL/F	Up to 25 days	Apparent clearance of drug after oral administration (CL/F)
Determination of CLr	Up to 25 days	Renal clearance (CLr)

Trial Locations

Locations (1)

Celerion, Inc.; 🇺🇸 Tempe, Arizona, United States