Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax：Maximum observed concentration
研究概览
简要总结
To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ranges from 18 to 27 kg/m2 (both ends included), and the body weight is ≥50 kg for men and ≥45 kg for women；
- •Fasting blood glucose during the screening is < 6.1 mmol/L；
排除标准
- •It has clinical significance for abnormalities Laboratory examination, if there is a clear reasonable reason, can be retested within a week, with the retest results Whether the subject meets the requirements
- •Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening;
- •Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)
研究组 & 干预措施
Treatment group A
HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
干预措施: HR17031 injection ；INS068 injection；SHR20004 injection (Drug)
Treatment group B
INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
干预措施: HR17031 injection ；INS068 injection；SHR20004 injection (Drug)
Treatment group C
SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
干预措施: HR17031 injection ；INS068 injection；SHR20004 injection (Drug)
Treatment group D
(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
干预措施: HR17031 injection ；INS068 injection；SHR20004 injection (Drug)
结局指标
主要结局
Cmax：Maximum observed concentration
时间窗: Day1 to Day 26
AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；
时间窗: Day1 to Day 26
AUC0-inf：Area under the curve from time 0 to infinity；
时间窗: Day1 to Day 26
次要结局
- Tmax ：time of maximum observed concentration(Day1 to Day 26)
- T1/2：Half-life time ；(Day1 to Day 26)
- CL/F(Day1 to Day 26)
- Vz/F(Day1 to Day 26)
- Serum glucose within 24h after injection(Day1 to Day 23)
- ADA：anti-drug antibody(Day 1、Day 8、Day15、Day 22 or early termination)
- C-peptide concentrations within 24h after injection(Day1 to Day 23)