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New drug ICP-538 tested in healthy people for first time

NCT ID NCT07535099

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase trial is testing the safety and tolerability of a new drug called ICP-538 in 104 healthy adults. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and how the drug moves through the body. The goal is to gather basic safety information, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ICP-538

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

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

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 50 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: 1. Voluntarily sign the ICF.. 2. BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg. 3. Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator. 4. Laboratory test results at screening and baseline are within the normal reference range. 5. Reproductive Status:Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants must not donate sperm during this period. Exclusion Criteria: 1. Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases . 2. Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption. 3. Acute illness within 14 days before dosing. 4. Severe infection within 6 months before dosing, or chronic/recurrent infections. 5. Participant and/or first-degree relative with hereditary immunodeficiency. 6. Major trauma or surgery within 3 months before dosing. 7. History of active/latent TB or contact with an open TB case within 6 months before dosing. 8. Positive urine drug screen. 9. Alcohol abuse. 10. Use of tobacco/nicotine products within 3 months before the first dose. 11. Use of any prescription/non-prescription drugs, herbal medicines, supplements within 14 days before first dose; or systemic corticosteroids, immunosuppressants/modulators, hormone replacement therapy within 30 days before first dose; or any other factor affecting drug absorption, distribution, metabolism, and excretion. 12. Consumption of caffeine-containing foods/beverages within 48 hours before the first dose. 13. Use of known CYP3A4 inducers/inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose. 14. Dieting, dietary therapy within 30 days before the first dose. 15. Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening. 16. Administration of live vaccines within 6 weeks before the first dose or planned during study or within 8 weeks after study.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Gobroad Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102200, China

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