A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults

A Phase 1, Single-center, Open-label, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose and Multiple Doses of EDG-7500 in Healthy Adult Caucasian and Japanese Participants

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: EDG-7500

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Edgewise Therapeutics, Inc.; Phone Number: 720-262-7002; Email: cardiacstudies@edgewisetx.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Parexel
      • Contact: Edgewise Therapeutics, Inc.; Phone Number: 720-262-7002; Email: cardiacstudies@edgewisetx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult, male or female, 18-55 years of age, inclusive.
• Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.
• Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.
• BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
• Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and <140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
• eGFR ≥ 80 mL/min/1.73 m2 calculated using the CKD-EPI formula at screening.
• Female and male participants must follow protocol-specified contraception guidance.

Exclusion Criteria:

• History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.
• History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).
• History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.
• History of plasma donation within 7 days prior to screening.
• History of use of tobacco- or nicotine-containing products within six months prior to screening.
• Participating in another interventional clinical study or has used an investigational drug within 30 days or 5 half-lives prior to screening.
• History of alcohol and/or illicit drug abuse within 2 years of study participation.
• Positive urine test for alcohol or a positive urine drug test at screening or check-in.
• Breastfeeding or has a positive serum pregnancy test at screening or check-in.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - Healthy Japanese Adults; Single and Multiple Dose EDG-7500	Drug: EDG-7500; Solid oral formulation of EDG-7500
Experimental: Cohort 2 - Healthy Japanese Adults; Single and Multiple Dose EDG-7500	Drug: EDG-7500; Solid oral formulation of EDG-7500
Experimental: Cohort 3 - Healthy Caucasian Adults; Single and Multiple Dose EDG-7500	Drug: EDG-7500; Solid oral formulation of EDG-7500

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-last	Area under the plasma concentration time-curve from time zero to the last measured concentration	Day 1 to Day 13
AUC0-inf	Area under the plasma concentration time-curve from time zero extrapolated to infinity	Day 1 to Day 13
AUCtau	Area under the concentration-time curve during the dosing interval	Day 1 to Day 13
Cmax	Maximum plasma concentration observed	Day 1 to Day 13
Cmax,ss	Maximum plasma concentration at steady state determined directly from the concentration-time profile	Day 1 to Day 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - TEAEs	Incidence of treatment-emergent adverse events	Up to 23 days of monitoring
Tmax	Time to maximum plasma concentration	Day 1 to Day 13
AUC%extrap	Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)	Day 1 to Day 13
CL/F	Total body clearance	Day 1 to Day 13
Vz/F	Apparent volume of distribution	Day 1 to Day 13
T1/2	Terminal elimination half-life	Day 1 to Day 13
Ctrough,ss	Trough plasma concentration at steady state	Day 1 to Day 13
Cavg,ss	Average plasma drug concentration during a dosing interval at steady state	Day 1 to Day 13
RA(AUCtau)	Accumulation ratio for the area under the concentration-time curve during the dosing interval	Day 1 to Day 13
RA(Cmax)	Accumulation ratio at the maximum concentration	Day 1 to Day 13

Collaborators and Investigators

• Sponsor: Edgewise Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EDG-7500-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No