Tiny study tracks heart Drug's journey in healthy men
NCT ID NCT07656779
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study will give a small dose of a radioactive-labeled drug called HRS-1893 to 6 healthy men. Researchers will track how the drug is absorbed, broken down, and eliminated through urine and feces. The goal is to understand the drug's path in the body, which is a key step before testing it as a treatment for heart muscle diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-1893 (a radioactive-labeled drug)
- What this could lead to
- If successful, this study will help researchers understand how HRS-1893 is processed and eliminated by the body, guiding future trials for heart muscle diseases.
- What could go wrong
- This is a very early Phase 1 study with only 6 healthy volunteers, not patients. It focuses on basic drug behavior, not treatment effects, so it may not lead to a therapy.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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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. Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male. 2. Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg. 3. After comprehensive physical examinations (including vital signs, physical examinations, etc.) and laboratory tests (such as blood routine, blood biochemistry, coagulation function, urine routine, fecal routine + occult blood, thyroid function), as well as abdominal B-ultrasound and chest anteroposterior X-ray films, no clinically significant abnormalities were found (ALT, AST, total bilirubin, direct bilirubin, creatine kinase must be \< 1.5 times the upper limit of the normal reference value, glomerular filtration rate (eGFR) \> 90 mL/(min·1.73 m2)), or the researchers judged that there were minor abnormalities that did not affect the participants' enrollment (such as hemangioma, cyst, calcification focus, nodules, etc.). Among them, abdominal B-ultrasound and chest anteroposterior X-ray films can accept the abdominal B-ultrasound or abdominal CT that can be traced within 6 months before administration, and the results of chest anteroposterior X-ray films or chest CT. 4. The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be \< 450 ms). 5. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person. Exclusion Criteria: 1. Systolic blood pressure (SBP) during the screening period or baseline period: SBP ≥ 140 mmHg or \< 90 mmHg; Diastolic blood pressure (DBP): DBP ≥ 90 mmHg or \< 60 mmHg, and the clinical doctor determines that it has clinical significance. 2. During the screening period, any one of the following infectious disease screenings - hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus antibody - showing any abnormal result and judged by the researcher to have clinical significance will be included. 3. There is a history of syncope in the past. 4. Those who have a history of allergies to drugs, foods, or the environment, or who are allergic to the test drug or any of its components. 5. Within one month prior to taking the research drug, any prescription drugs, over-the-counter drugs, or herbal medicines were taken; those whose drug half-life was within five half-lives at the time of screening; and those who plan to take non-research trial drugs during the trial period. 6. Select those who smoked an average of more than 5 cigarettes per day over the past 4 weeks; those who consumed an average of more than 15 grams of alcohol per day in a week (15 grams of alcohol is equivalent to 450 mL of beer or 150 mL of wine or 50 mL of low-alcohol liquor); or those whose alcohol breath test result was greater than 0 mg/100 mL during the screening period; or those who refrained from smoking, drinking alcohol and consuming caffeinated foods or beverages during the screening period and the test period, and had special dietary requirements that they could not comply with the unified diet. 7. Habitual constipation or diarrhea. 8. Those with a history of drug use or substance abuse; or those who tested positive for drug abuse in the screening urine test during the selection process. 9. Those who habitually consume grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages, or those who are unable to quit during the trial period. 10. Those who have a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection. 11. Screen those who have participated in any clinical trials of drugs or medical devices within the past three months (the definition of participation in clinical trials is based on the participants receiving treatment with the trial drugs or medical devices). 12. Those who received the vaccine within the previous 1 month or during the trial period or within 1 month after administration. 13. Those who had experienced blood loss or blood donation of 400 mL within the past 3 months, or those who received blood transfusion within the past 1 month will be selected. 14. Staff members of the research center or other individuals directly involved in the implementation of the plan. 15. The researchers believe that there are other circumstances that make the participants unsuitable for this trial, such as those that might increase the risk of the trial, affect the participants' compliance with the protocol, or cause physical or psychological conditions that prevent them from completing the trial.
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Conditions
The condition(s) this trial relates to.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, 214100, China
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Other studies related to the condition(s) this trial covers.
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