A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults (NCT07456059) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults
United States24 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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-contain…