Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants (NCT07494175) | Clinical Trial Compass
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 range18 Years – 45 Years
SexMALE
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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;
✕. During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
✕. Participants who test positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), syphilis antibody, or human immunodeficiency virus antibody (anti-HIV);
✕. Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
What they're measuring
1
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
Timeframe: From 0 to 120 hours after dosing
2
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma
Timeframe: From 0 to 120 hours after dosing
3
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
4
List of metabolites identified in plasma, urine, and feces