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.

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.