Not Yet RecruitingPhase 1

A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects

China6 participantsStarted 2026-05

Plain-language summary

The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]HRS-1780 following an oral single dose in healthy adult male participants.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be willing to complete the research as required by the trial protocol.
✓. Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.
✓. Body weight of no less than 50 kg and a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (inclusive).
✓. Participants (including their partners) shall have no intention to have children or donate sperm within three months after signing the informed consent form and shall voluntarily adopt the contraceptive measures stipulated in the protocol.

Exclusion criteria

✕. Clinically significant abnormalities in vital signs (complete physical examination, laboratory tests, biochemistry, urinalysis, coagulation function, stool routine and occult blood, thyroid function), 12-lead electrocardiogram, digital rectal examination, chest X-rays, abdominal ultrasound.
✕. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.
✕. Receipt of medical devices or another investigational drug (including placebo) within the previous 3 months or within the 5 half-lives (whichever is longer), and plan to participate in other clinical trials of drugs or medical devices during the trial period.
✕. History of illicit or prescription drug abuse in the past five years or drug addiction within 3 months of screening, or positive urine drug screen at screening/baseline.
✕. Use of any prescription medicine within 2 weeks, or over-the-counter (OTC) medicine, herbal remedy, or nutritional supplement, or within 5 half-lives of any drugs, whichever is longer prior to dosing, except for vitamins and occasional use of paracetamol (≤ 2 g/day; no more than 3 consecutive days).
✕. History or evidence of clinically significant disorders (including but not limited to immunologic, hepatic, renal, digestive, urinary, psychiatric, respiratory, hematologic, endocrine, or metabolic disorders) and deemed not suitable to participate in the study by the investigator.
✕. Severe systemic infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plan to do surgeries during the study.
✕. Whole blood/plasma donation or loss ≥ 200 mL of blood within 3 months prior to dosing; received a blood/plasma transfusion.

What they're measuring

Total radioactivity ratio of whole blood/plasma.

Timeframe: 0 to anticipated 11 days.

Tmax

Timeframe: 0 to anticipated 11 days.

Cmax

Timeframe: 0 to anticipated 11 days.

AUClast

Timeframe: 0 to anticipated 11 days.

AUC0-inf

Timeframe: 0 to anticipated 11 days.

t1/2

Timeframe: 0 to anticipated 11 days.

CL/F

Timeframe: 0 to anticipated 11 days.

Vz/F

Timeframe: 0 to anticipated 11 days.

%AUC

Timeframe: 0 to anticipated 11 days.

Trial details

NCT IDNCT07557407

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Jing He

+86-0518-82342973 jing.he@hengrui.com

View on ClinicalTrials.gov More Chronic Kidney Diseases trials

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be willing to complete the research as required by the trial protocol.
✓. Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.
✓. Body weight of no less than 50 kg and a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (inclusive).
✓. Participants (including their partners) shall have no intention to have children or donate sperm within three months after signing the informed consent form and shall voluntarily adopt the contraceptive measures stipulated in the protocol.

Exclusion criteria

✕. Clinically significant abnormalities in vital signs (complete physical examination, laboratory tests, biochemistry, urinalysis, coagulation function, stool routine and occult blood, thyroid function), 12-lead electrocardiogram, digital rectal examination, chest X-rays, abdominal ultrasound.
✕. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.
✕. Receipt of medical devices or another investigational drug (including placebo) within the previous 3 months or within the 5 half-lives (whichever is longer), and plan to participate in other clinical trials of drugs or medical devices during the trial period.
✕. History of illicit or prescription drug abuse in the past five years or drug addiction within 3 months of screening, or positive urine drug screen at screening/baseline.
✕. Use of any prescription medicine within 2 weeks, or over-the-counter (OTC) medicine, herbal remedy, or nutritional supplement, or within 5 half-lives of any drugs, whichever is longer prior to dosing, except for vitamins and occasional use of paracetamol (≤ 2 g/day; no more than 3 consecutive days).
✕. History or evidence of clinically significant disorders (including but not limited to immunologic, hepatic, renal, digestive, urinary, psychiatric, respiratory, hematologic, endocrine, or metabolic disorders) and deemed not suitable to participate in the study by the investigator.
✕. Severe systemic infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plan to do surgeries during the study.
✕. Whole blood/plasma donation or loss ≥ 200 mL of blood within 3 months prior to dosing; received a blood/plasma transfusion.

What they're measuring

Total radioactivity ratio of whole blood/plasma.

Timeframe: 0 to anticipated 11 days.

Tmax

Timeframe: 0 to anticipated 11 days.

Cmax

Timeframe: 0 to anticipated 11 days.

AUClast

Timeframe: 0 to anticipated 11 days.

AUC0-inf

Timeframe: 0 to anticipated 11 days.

t1/2

Timeframe: 0 to anticipated 11 days.

CL/F

Timeframe: 0 to anticipated 11 days.

Vz/F

Timeframe: 0 to anticipated 11 days.

%AUC

Timeframe: 0 to anticipated 11 days.