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

NCT07764705 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-10504-115
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects

Keywords

Phase I; Mass balance; HS-10504; Healthy participants

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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)

  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.

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

• Cmax

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

• Tmax

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

• AUC0-t

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

Study Arms (1)

Experimental group

EXPERIMENTAL

Mass balance Arm

Drug: [¹⁴C]HS-10504

Interventions

[¹⁴C]HS-10504 DRUG

\[¹⁴C\]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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 14, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08