A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Have a history of drug allergy, specific allergy, or allergic constitution
- •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 a history of risk factors for torsade de pointes
- •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
- •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
- •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
- •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
- •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
- •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
研究组 & 干预措施
Dose Level：A
Subject will receive [14C]HRS-9057 at dose level A
干预措施: [14C]HRS-9057 (Drug)
结局指标
主要结局
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax
时间窗: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2
时间窗: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT
时间窗: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC
时间窗: From Day 1 to Day 28
Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period
时间窗: 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)
时间窗: 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)
时间窗: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax
时间窗: From Day 1 to Day 28
次要结局
- Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax(From Day 1 to Day 28)
- Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax(From Day 1 to Day 28)
- Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2(From Day 1 to Day 28)
- Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT(From Day 1 to Day 28)
- Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC(From Day 1 to Day 28)
- Serious adverse events(From ICF signing date to Day 28)