A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects (NCT07557407) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
MALE
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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
%AUC
Timeframe: 0 to anticipated 11 days.
10
%Dose
Timeframe: 0 to anticipated 11 days.
11
Total radioactivity ratio for blood/plasma.
Timeframe: 0 to anticipated 11 days.
12
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces.