Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Multiple Dose of SHR3824 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Halflife of SHR3824.
研究概览
简要总结
SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort SHR3824/Placebo 1.25 mg
SHR3824 1.25 mg/day or placebo for 10 days.
干预措施: SHR3824 (Drug)
Cohort SHR3824/Placebo 1.25 mg
SHR3824 1.25 mg/day or placebo for 10 days.
干预措施: Placebo (Drug)
Cohort SHR3824/Placebo 2.5 mg
SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: SHR3824 (Drug)
Cohort SHR3824/Placebo 2.5 mg
SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: Placebo (Drug)
Cohort SHR3824/Placebo 5 mg
SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: SHR3824 (Drug)
Cohort SHR3824/Placebo 10 mg
SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: Placebo (Drug)
Cohort SHR3824/Placebo 5 mg
SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: Placebo (Drug)
Cohort SHR3824/Placebo 10 mg
SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: SHR3824 (Drug)
Cohort SHR3824/Placebo 25 mg
SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: SHR3824 (Drug)
Cohort SHR3824/Placebo 25 mg
SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: Placebo (Drug)
Cohort SHR3824/Placebo 100mg
SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: SHR3824 (Drug)
Cohort SHR3824/Placebo 100mg
SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
干预措施: Placebo (Drug)
结局指标
主要结局
Halflife of SHR3824.
时间窗: day1 and day11 to day 13.
CL/F of SHR3824.
时间窗: day1 and day11 to day 13.
V/F of SHR3824.
时间窗: day1 and day11 to day 13.
AUC(Area under the curve) of SHR3824.
时间窗: day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.
时间窗: day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.
时间窗: day1 and day11 to day 13.
Accumulation ratio of SHR3824
时间窗: Up to day 13.
Urine glucose concentration of SHR3824.
时间窗: day1 and day11
Plasma glucose concentration of SHR3824.
时间窗: day1 and day11
次要结局
- Adverse events, vital signs, physical exams , ECG, clinical labs(Days -14 to -1, 0, 13.)
- Serum creatinine(Days -14 to -1, 0, 2, 9, 13.)