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
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.
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mass balance Arm
Drug: [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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
No study locations are listed for this record.
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.
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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Studies of the drug tested here: HS-10504
Jiangsu Hansoh Pharmaceutical Co., Ltd. →