A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants (NCT07681479) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
China6 participantsStarted 2026-07
Plain-language summary
This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up
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.
. Have a history of drug allergy, specific allergy, or allergic constitution
. Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo
. Have a history of risk factors for torsade de pointes
. During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL/min/1.73m2
. During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms
. Chest X-ray findings deemed clinically significant by the investigator
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.
What they're measuring
1
Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period
Timeframe: From Day 1 to Day 28
2
Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)
Timeframe: From Day 1 to Day 8
3
The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)
Timeframe: From Day 1 to Day 28
4
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax
Timeframe: From Day 1 to Day 28
5
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax
Timeframe: From Day 1 to Day 28
6
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2
. Have positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or treponema pallidum antibody or nonnegative test result for human immunodeficiency virus (HIV) during the screening period
. Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT
Timeframe: From Day 1 to Day 28
8
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC