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Scientists track mystery Drug's journey through healthy volunteers

NCT ID NCT07644442

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This completed Phase 1 study gave 6 healthy Chinese men a single oral dose of a radiolabeled drug called HMPL-453 to see how it is absorbed, broken down, and eliminated. Researchers measured radioactivity in blood, urine, and feces over time. The goal was not to treat any disease but to understand the drug's path in the body, which is essential for planning future studies.

What this could mean

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

Active substance
HMPL-453 (a drug being studied, given as a single oral dose with a radioactive tracer)
What this could lead to
If successful, this study will show how HMPL-453 moves through and leaves the body, helping design future trials for diseases it may treat.
What could go wrong
This is a very early, small study in just 6 healthy men, not patients. It only tracks the drug's path in the body and does not test if it works for any disease.

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

6 people

The number who actually took part.

Started

Feb 2025

Finished

Mar 2025

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 45 years

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. The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol; 2. Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form); 3. Body weight ≥50 kg, body mass index (BMI) 19\~26 kg/m2 (including limit values); 4. Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used. Exclusion Criteria: 1. History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study; 2. History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg; 3. Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system; 4. History of gastrointestinal surgery, kidney surgery, cholecystectomy, etc., which the researchers judge may affect drug absorption or excretion; 5. Abnormal ophthalmological examination results have clinical significance, corrected visual acuity \<1.0 or with the following history of eye diseases: non-arteritic anterior ischemic optic neuropathy (NAION), color vision abnormalities, hereditary retinal degeneration (such as pigmentary retinopathy), macular degeneration, retinal detachment, corneal lesions confirmed by ophthalmological examination, including but not limited to bullous keratopathy, band keratopathy, corneal abrasion, corneal ulcer, keratitis, etc.; 6. Anal diseases with periodic/ongoing bleeding; 7. History of vomiting and diarrhea within the past week; 8. Subjects who have used any prescription drugs within the past 30 days; 9. History of any non-prescription drugs and herbal supplements (including but not limited to vitamins, preventive treatments, Chinese herbal medicines, plant-based health products, etc.) taken within the past 14 days; 10. Screening period vital signs, physical examination, chest frontal and lateral films, and laboratory tests (including routine blood tests, blood biochemistry, routine urine tests, thyroid function, coagulation function, stool analysis, etc.) results are judged by the researcher to be clinically significant abnormalities (CS); 11. During the screening period, clinically significant abnormalities appear on the 12-lead ECG, or baseline QTcF interval \>450 ms, or there is a history of QTc interval prolongation syndrome or sudden death in the family. If the ECG cannot display the QTcF result, please use the following formula to calculate: QTcF=QT/∛RR (RR=60/heart rate); 12. Creatinine clearance rate ≤90 mL/min estimated by the Cockcroft-Gault formula \[(140-age) × weight (kg)\] / \[72 × serum creatinine (mg/dL)\]; 13. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, or syphilis spirochete antibody; 14. Irregular or difficult bowel movements, or other conditions that the researcher determines may affect stool sample collection; 15. Subjects who smoked more than 10 cigarettes per day in the past 3 months, and could not completely quit smoking during the study period; 16. Frequent drinkers in the past 6 months, i.e., those who drink more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or those who test positive for alcohol breath test during the screening period; 17. Drug abuse or dependence, or positive urine drug abuse screening; 18. Subjects consumed foods, juices or beverages containing alcohol, grapefruit, pomelo, citron, orange and caffeine within 72 hours prior to the first dose, and did not agree to abstain from them during the study period; 19. Subjects who have used blood products within the past 2 months; screen for those who have donated blood (including component donation) or lost ≥400 mL of blood within the past 3 months, screen for those who have donated blood (including component donation) or lost ≥200 mL of blood within the past 1 month, or plan to donate blood or blood components during the study period or within 1 month after the end of the study; 20. Poor venous blood collection assessment, fear of needles, fear of blood or difficulty in collecting venous blood; 21. Having participating in other drug clinical trials within the past three months; 22. Workers engaged in work that requires long-term exposure to radioactive conditions; or those who have had significant radiation exposure within 1 year prior to administration \[≥2 chest/abdominal computed tomography (CT) scans, or ≥3 other types of X-ray examinations\] or participated in radioactive drug labeling trials; 23. Subjects who have been vaccinated within 30 days before administration, and those who plan to be vaccinated within two weeks after administration; 24. According to the researchers' judgment, the subject has any other disease or condition that may affect the normal completion of the experiment or the evaluation of the research data, or any other situation that is not suitable for participating in this study. -

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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

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

    Jinan, Shandong, 250000, China

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