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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • [¹⁴C]HS-10504

Treatment groups

6 Participants
are divided into 1 treatment group

Locations

This trial has no locations