Human Mass Balance Study of [¹⁴C]HRS-1893 (NCT07656779) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Human Mass Balance Study of [¹⁴C]HRS-1893
China6 participantsStarted 2026-06
Plain-language summary
HRS-1893-107 is a Phase 1, single-center, non-randomized, open-label, single-dose study designed to investigate the mass balance, metabolism, and pharmacokinetics of \[14C\]HRS-1893. The study aims to quantify the radioactive recovery rate, determine the primary excretion pathways, evaluate the whole blood-to-plasma radioactivity ratio, identify major metabolites, and characterize the pharmacokinetic (PK) profile of HRS-1893 and its metabolites. Safety and tolerability will be monitored throughout the trial.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male.
. Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a radioactive form of HRS-1893 called [¹⁴C] to track how the drug moves through the body — what does that mean for my radiation exposure, and is that level considered safe?
2Since this is a Phase 1 mass balance study focused on how the drug is absorbed, broken down, and excreted rather than whether it treats cardiomyopathy, would joining it offer me any direct treatment benefit at this stage?
3The trial measures drug levels in both urine and feces over time, which suggests participants need to collect samples over an extended period — how long would I need to stay at the study site, and how would that fit with my day-to-day life and current care needs?
4This study hasn't started recruiting yet — given where I am in my cardiomyopathy diagnosis, would it make more sense to pursue an established treatment now rather than waiting for this early-phase research study to open?
5Because the main goal here is understanding how HRS-1893 breaks down in the body rather than testing its effectiveness, what is actually known so far about whether this drug might help people with my type of cardiomyopathy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total radioactivity ratio of whole blood/plasma
Timeframe: 0 to anticipated 11 days.
2
Time to reach maximum concentration (Tmax)
Timeframe: 0 to anticipated 11 days.
3
Maximum concentration (Cmax)
Timeframe: 0 to anticipated 11 days.
4
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
Timeframe: 0 to anticipated 11 days.
5
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
. The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be \< 450 ms).
. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
Exclusion criteria
. 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.
. 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.
. There is a history of syncope in the past.
. 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.
. 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.
. 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.
. Habitual constipation or diarrhea.
. 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.
Apparent volume of distribution (V/F)
Timeframe: 0 to anticipated 11 days.
9
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Timeframe: 0 to anticipated 11 days.
10
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Timeframe: 0 to anticipated 11 days.
11
Total radioactivity ratio for blood/plasma
Timeframe: 0 to anticipated 11 days.
12
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces