ClinicalTrials.gg
Not yet recruitingNCT07764705Updated Aug 14, 2026

A Mass Balance Study of [14C]HS-10504

A Phase 1 interventional study of [¹⁴C]HS-10504 in Healthy Subjects, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Not yet recruiting. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. (part of Hansoh Pharmaceutical Group Company Limited) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Phase I
  • Mass balance
  • HS-10504
  • Healthy participants
03

In context

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 137 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects must be healthy adult males.
  2. Aged 18 years or older.
  3. between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive).
  4. Able and willing to provide written voluntarily.

Exclusion criteria

Exclusion Criteria:

  1. 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 , 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.;
  2. 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 of less than 7 half-lives (whichever is longer) before screening;
  3. Participation in other clinical trials and use of other drugs or devices within 3 months prior to screening or during the screening period, or planned participation in another clinical trial during this study;
  4. 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;
  5. Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed;
  6. Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to the participant;
  7. Predisposition to allergic reactions, or allergic constitution (e.g., allergy to pollen, any drugs/foods), or history of severe allergy;
  8. Lactose intolerance;
  9. Habitual constipation or diarrhea;
  10. 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;
  11. 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;
  12. 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;
  13. 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;
  14. Vaccination within 1 month prior to screening, or planned vaccination during the study;
  15. History of syncope due to needle or blood, difficulty in blood sampling, or intolerance to venipuncture;
  16. Plans to father a child or donate sperm (for male participants) from signing of to 1 year after study completion, or unwillingness to adopt strict measures with their spouse/partner during this period;
  17. 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;
  18. Special dietary requirements that cannot be complied with the standardized diet;
  19. Other reasons judged by the investigator as unsuitable for participation, or withdrawal of the participant's own accord.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Mass balance Arm

    Drug: [¹⁴C]HS-10504

Interventions

  • \[¹⁴C\]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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    Time frame: Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.

  4. 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.

    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.

Secondary outcomes

  1. total radioactivity in human plasma and whole blood (if applicable)

    To evaluate 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.

  2. 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.

    Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.

  3. Cmax

    To evaluate the Cmax of HS-10504 and its metabolite M6-2 in plasma.

    Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.

  4. Tmax

    To evaluate the Tmax of HS-10504 and its metabolite M6-2 in plasma.

    Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.

  5. AUC0-t

    To evaluate the AUC0-t of HS-10504 and its metabolite M6-2 in plasma.

    Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.

  6. AUC0-∞

    To evaluate the AUC0-∞ of HS-10504 and its metabolite M6-2 in plasma.

    Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.

  7. 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

    Time frame: Up to end of the study, approximately 3 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Sep 2026, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Aug 14, 2026
StartEst.
Jul 30, 2026
Primary completionEst.
Sep 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07764705
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Jul 30, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: HS-10504

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