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
Eligibility
Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period — From Day 1 to Day 28
Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC) — From Day 1 to Day 8
The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose) — From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax — From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax — From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2 — From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT — From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC — From Day 1 to Day 28
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )
Nanjing
Jiangsu
More Fujian Shengdi Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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