Healthy SubjectsPhase 1NCT07764705
A Mass Balance Study of [14C]HS-10504
A Phase 1 study testing [¹⁴C]HS-10504 in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of [14C] HS-10504 in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- [¹⁴C]HS-10504
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Dec 2027
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be healthy adult males.
- Aged 18 years or older.
- BMI between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive).
- Able and willing to provide written informed consent voluntarily.
Who cannot join
- 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.;
- 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;
- 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;
- 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;
- Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed;
- Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to the participant;
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- Predisposition to allergic reactions, or allergic constitution (e.g., allergy to pollen, any drugs/foods), or history of severe allergy;
- Lactose intolerance;
- Habitual constipation or diarrhea;
- 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;
- 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;
- 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;
- 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;
- Vaccination within 1 month prior to screening, or planned vaccination during the study;
- History of syncope due to needle or blood, difficulty in blood sampling, or intolerance to venipuncture;
- 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;
- 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;
- Special dietary requirements that cannot be complied with the standardized diet;
- Other reasons judged by the investigator as unsuitable for participation, or withdrawal of the participant's own accord.
About this study
Official title: A Mass Balance Study of [14C]HS-10504 in Healthy Adult Male Chinese Participants
This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of [14C] HS-10504 in healthy adult male subjects.
- Conditions
- Healthy Subjects
- Being tested
- [¹⁴C]HS-10504
- Keywords
- Phase I, Mass balance, HS-10504, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]HS-10504Drug
[¹⁴C]HS-10504: Participants will receive a single oral administration of approximately 400 mg/200 μCi [¹⁴C]HS-10504 under fasting conditions on day 1 morning.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Mass balance Arm Receives: Drug: [¹⁴C]HS-10504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radiorecovery and cumulative radiorecovery in urine and feces per time interval.
To assess the routes and rates of elimination of HS-10504 and its metabolites after single oral administration of [14C]HS-10504 in healthy adult male participants.
Measured: All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
Percentage of major metabolites in human plasma, urine, and feces.
To determine the metabolism and elimination pathways of HS-10504 after single oral administration of [14C]HS-10504 in healthy adult male subjects, and identify major metabolites.
Measured: Plasma, urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
The percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites (%AUC).
To evaluate the percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites.
Measured: Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
The percentage of the administered dose recovered as parent drug and metabolites in urine and feces
To evaluate the percentage of the administered dose recovered as parent drug and metabolites in urine and feces.
Measured: Urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
Secondary outcomes (7)
total radioactivity in human plasma and whole blood (if applicable)
To evaluate total radioactivity in human plasma and whole blood (if applicable)
Measured: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.
the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.
Measured: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Cmax
To evaluate the Cmax of HS-10504 and its metabolite M6-2 in plasma.
Measured: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Tmax
To evaluate the Tmax of HS-10504 and its metabolite M6-2 in plasma.
Measured: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
AUC0-t
To evaluate the AUC0-t of HS-10504 and its metabolite M6-2 in plasma.
Measured: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
AUC0-∞
To evaluate the AUC0-∞ of HS-10504 and its metabolite M6-2 in plasma.
Measured: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
To assess the safety and tolerability of a single oral dose of approximately [14C] HS-10504 in healthy adult male subjects
Measured: Up to end of the study, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764705
- Sponsor's protocol ID
- HS-10504-115
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of [14C]HS-10504 in Healthy Adult Male Chinese Participants
- ClinicalTrials.gov ID
- NCT07764705
- Acronym / sponsor ID
- HS-10504-115
- Conditions
- Healthy Subjects
- Keywords
- Phase I, Mass balance, HS-10504, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Aug 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.
This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of [14C] HS-10504 in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: [¹⁴C]HS-10504Mass balance Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be healthy adult males.
- Aged 18 years or older.
- BMI between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive).
- Able and willing to provide written informed consent voluntarily.
Key exclusion criteria (19 listed)
- 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.;
- 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;
- 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;
- 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;
- Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed;
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]HS-10504[¹⁴C]HS-10504: Participants will receive a single oral administration of approximately 400 mg/200 μCi [¹⁴C]HS-10504 under fasting conditions on day 1 morning. | Drug | Experimental group |
Primary outcome
Total radiorecovery and cumulative radiorecovery in urine and feces per time interval.
Time frame: All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
To assess the routes and rates of elimination of HS-10504 and its metabolites after single oral administration of [14C]HS-10504 in healthy adult male participants.
Percentage of major metabolites in human plasma, urine, and feces.
Time frame: Plasma, urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
To determine the metabolism and elimination pathways of HS-10504 after single oral administration of [14C]HS-10504 in healthy adult male subjects, and identify major metabolites.
The percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites (%AUC).
Time frame: Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
To evaluate the percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites.
The percentage of the administered dose recovered as parent drug and metabolites in urine and feces
Time frame: Urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
To evaluate the percentage of the administered dose recovered as parent drug and metabolites in urine and feces.
7 secondary outcomes
total radioactivity in human plasma and whole blood (if applicable)
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Cmax
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Tmax
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
AUC0-t
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
AUC0-∞
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: Up to end of the study, approximately 3 months
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 14 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [¹⁴C]HS-10504 in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
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 4 inclusion and 19 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radiorecovery and cumulative radiorecovery in urine and feces per time interval. (time frame: All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.). The study lists 4 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 14 Aug 2026.