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

Korábbi kezelés

• 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 used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing
• Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration

Más betegség

• Have a history of drug allergy, specific allergy, or allergic constitution
• Have a history of risk factors for torsade de pointes
• 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
• All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea
• 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

Laborértékek

• 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

Egyéb

• 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
• 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

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