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New drug EDG-7500 tested in healthy volunteers

NCT ID NCT07456059

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Parexel

    Glendale, California, 91206, United States

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