A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants

A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants

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

Inclusion Criteria:

1. Informed consent was obtained voluntarily
2. Healthy males aged 18 ~ 45 years (inclusive)
3. Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)
4. Adopt efficient contraceptive measures

Exclusion Criteria:

1. Have a history of drug allergy, specific allergy, or allergic constitution
2. 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
3. Have a history of risk factors for torsade de pointes
4. 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
5. During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms
6. Chest X-ray findings deemed clinically significant by the investigator
7. 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
8. Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing
9. Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration
10. All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea
11. Workers engaged in conditions requiring long-term exposure to radioactivity; Or had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year before the trial or had participated in a radiolabeled drug trial within 1 year
12. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment