New drug EDG-7500 tested in healthy volunteers
NCT ID NCT07456059
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-stage study tests the safety of a new drug called EDG-7500 in 24 healthy adults, both Japanese and Caucasian. Participants receive single or multiple doses, and researchers measure how the drug moves through the body. No treatment benefit is expected; the goal is to gather safety and dosing information.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Mar 2026
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Parexel
Glendale, California, 91206, United States
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