Active — Not RecruitingPhase 1

Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

China6 participantsStarted 2026-04-11

Plain-language summary

To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy 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

. The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
. Male participants aged between 18 and 45 years old (inclusive);
. ASA =I;
. Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
. Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

Exclusion criteria

. Participants with a history of or current acute or chronic clinical diseases
. Participants with a history of neuromuscular diseases;
. Participants with a history of anesthetic complications;
. Participants with a history of airway diseases;
. Participants who have undergone major surgery within 6 months prior to screening;

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

Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta

Timeframe: From 0 to 120 hours after dosing

Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma

Timeframe: From 0 to 120 hours after dosing

Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose

Timeframe: From 0 to 120 hours after dosing

List of metabolites identified in plasma, urine, and feces

Timeframe: From 0 to 120 hours after dosing

Total radioactive pharmacokinetic parameter Tmax

Timeframe: From 0 to 120 hours after dosing

Total radioactive pharmacokinetic parameter Cmax

Timeframe: From 0 to 120 hours after dosing

Total radioactive pharmacokinetic parameter t1/2

Timeframe: From 0 to 120 hours after dosing

Trial details

NCT IDNCT07494175

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Healthy Adult Male trials

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

. The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
. Male participants aged between 18 and 45 years old (inclusive);
. ASA =I;
. Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
. Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

Exclusion criteria

. Participants with a history of or current acute or chronic clinical diseases
. Participants with a history of neuromuscular diseases;
. Participants with a history of anesthetic complications;
. Participants with a history of airway diseases;
. Participants who have undergone major surgery within 6 months prior to screening;

What they're measuring

Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta

Timeframe: From 0 to 120 hours after dosing

Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma

Timeframe: From 0 to 120 hours after dosing

Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose

Timeframe: From 0 to 120 hours after dosing

List of metabolites identified in plasma, urine, and feces

Timeframe: From 0 to 120 hours after dosing

Total radioactive pharmacokinetic parameter Tmax

Timeframe: From 0 to 120 hours after dosing

Total radioactive pharmacokinetic parameter Cmax

Timeframe: From 0 to 120 hours after dosing

Total radioactive pharmacokinetic parameter t1/2

Timeframe: From 0 to 120 hours after dosing