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Radioactive tracer reveals the Body's journey of an experimental drug

NCT ID NCT07764705

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This early-stage trial aims to understand how the experimental drug HS-10504 is absorbed, broken down, and eliminated from the body. A small group of healthy adult men will receive a single oral dose of the drug, which is labeled with a radioactive tracer to track its path. By measuring radioactivity in blood, urine, and feces, researchers hope to learn the drug's metabolism and excretion routes, which is essential for future development.

What this could mean

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

Active substance
A single oral dose of a radioactively labeled experimental drug called [14C]HS-10504
What this could lead to
If successful, this study could help researchers understand how HS-10504 is processed by the body, which is a key step in developing it as a potential treatment.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It focuses on drug metabolism, not on whether the drug works for any disease. Results may not predict effectiveness or safety in patients.

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 6 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 years and older

Sex

Male participants only

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. Subjects must be healthy adult males. 2. Aged 18 years or older. 3. BMI between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive). 4. Able and willing to provide written informed consent voluntarily. Exclusion Criteria: 1. Clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, thyroid function, coagulation function, urinalysis, stool routine and occult blood), 12-lead electrocardiogram, ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), chest X-ray (posteroanterior view), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, and spleen), urinary system ultrasound (kidney, ureter, bladder, and prostate), echocardiography, etc.; 2. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (except topical agents with local effects) within 30 days prior to screening, or use of any drug with a washout period of less than 7 half-lives (whichever is longer) before screening; 3. Participation in other clinical trials and use of other investigational drugs or devices within 3 months prior to screening or during the screening period, or planned participation in another clinical trial during this study; 4. History of any clinically significant disease or condition that may affect the study results, as judged by the investigator, including but not limited to cardiovascular, respiratory, endocrine, neurological, digestive, urinary, or hematological, immune, psychiatric, or metabolic diseases; or onset of a new illness before study drug administration that is considered by the investigator to make the subject unsuitable for participation; 5. Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed; 6. Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to the participant; 7. Predisposition to allergic reactions, or allergic constitution (e.g., allergy to pollen, any drugs/foods), or history of severe allergy; 8. Lactose intolerance; 9. Habitual constipation or diarrhea; 10. Frequent alcohol consumption within 3 months prior to screening, or inability to abstain from alcohol products during hospitalization; or a positive alcohol breath test at screening; 11. Average daily cigarette consumption \>5 cigarettes or habitual use of nicotine-containing products within 3 months prior to screening, or inability to abstain from any tobacco products during hospitalization; 12. Drug abuse, or use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., amphetamines, phencyclidine, etc.) within 1 year prior to screening; or a positive urine drug abuse (illicit drug) test at screening; 13. Employment in occupations requiring long-term exposure to radioactive conditions; or significant radiation exposure within 1 year prior to the study, or participation in radiopharmaceutical labeling studies within 1 year prior to the study; 14. Vaccination within 1 month prior to screening, or planned vaccination during the study; 15. History of syncope due to needle or blood, difficulty in blood sampling, or intolerance to venipuncture; 16. Plans to father a child or donate sperm (for male participants) from signing of informed consent to 1 year after study completion, or unwillingness to adopt strict contraceptive measures with their spouse/partner during this period; 17. Blood loss ≥400 mL or blood donation within 3 months prior to screening; or blood loss ≥200 mL within 1 month; or blood transfusion within 1 month; or planned blood donation within 3 months after study completion; 18. Special dietary requirements that cannot be complied with the standardized diet; 19. Other reasons judged by the investigator as unsuitable for participation, or withdrawal of the participant's own accord.

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As listed by the trial registrant

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How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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