New drug ICP-538 tested in healthy people for first time
NCT ID NCT07535099
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 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: 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Health services research are added.
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBeijing, Beijing Municipality, 102200, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a conversation change health? training doctors to listen
- Can the right assistive device lighten a Caregiver's load?
- Could your local pharmacy become a hearing care hub?
- AI listens in to free up Doctors' time
- Survey reveals top priorities for Home-Based palliative care
- App aims to streamline doctor visits by letting patients log symptoms in advance