CardiomyopathiesPhase 1NCT07656779
Human Mass Balance Study of [¹⁴C]HRS-1893
A Phase 1 study testing [14C]HRS-1893 in people with Cardiomyopathies, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- [14C]HRS-1893
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- 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).
- Those who received the vaccine within the previous 1 month or during the trial period or within 1 month after administration.
- 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.
- Staff members of the research center or other individuals directly involved in the implementation of the plan.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, 214100
Yiqing Zhao, +86-0510-88682779, 13358100007@126.com
Yiqing Zhao
About this study
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.
- Conditions
- Cardiomyopathies
- Being tested
- [14C]HRS-1893
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]HRS-1893Drug
[14C]HRS-1893 suspension.
| Study group | Role | What they receive |
|---|---|---|
| [14C]HRS-1893 Group | Experimental | [14C]HRS-1893. Receives: Drug: [14C]HRS-1893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity ratio of whole blood/plasma
Measured: 0 to anticipated 11 days.
Time to reach maximum concentration (Tmax)
Measured: 0 to anticipated 11 days.
Maximum concentration (Cmax)
Measured: 0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
Measured: 0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
Measured: 0 to anticipated 11 days.
Half-life (t1/2)
Measured: 0 to anticipated 11 days.
Apparent clearance (CL/F)
Measured: 0 to anticipated 11 days.
Apparent volume of distribution (V/F)
Measured: 0 to anticipated 11 days.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Measured: 0 to anticipated 11 days.
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Measured: 0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma
Measured: 0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces
Measured: 0 to anticipated 11 days.
Secondary outcomes (1)
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Measured: 0 to anticipated 11 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-dose, non-randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656779
- Sponsor's protocol ID
- HRS-1893-107
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Mass Balance Study of [¹⁴C]HRS-1893
- ClinicalTrials.gov ID
- NCT07656779
- Acronym / sponsor ID
- HRS-1893-107
- Conditions
- Cardiomyopathies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-dose, non-randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| [14C]HRS-1893 Group | Experimental | Drug: [14C]HRS-1893[14C]HRS-1893. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]HRS-1893[14C]HRS-1893 suspension. | Drug | [14C]HRS-1893 Group |
Primary outcome
Total radioactivity ratio of whole blood/plasma
Time frame: 0 to anticipated 11 days.
Time to reach maximum concentration (Tmax)
Time frame: 0 to anticipated 11 days.
Maximum concentration (Cmax)
Time frame: 0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
Time frame: 0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
Time frame: 0 to anticipated 11 days.
Half-life (t1/2)
Time frame: 0 to anticipated 11 days.
Apparent clearance (CL/F)
Time frame: 0 to anticipated 11 days.
Apparent volume of distribution (V/F)
Time frame: 0 to anticipated 11 days.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Time frame: 0 to anticipated 11 days.
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Time frame: 0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma
Time frame: 0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces
Time frame: 0 to anticipated 11 days.
1 secondary outcome
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Time frame: 0 to anticipated 11 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]HRS-1893 in people with Cardiomyopathies, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenzheng Xiong (+86-0518-82342973, wenzheng.xiong.wx10@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity ratio of whole blood/plasma (time frame: 0 to anticipated 11 days.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.