A Randomized, Double-blinded, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HMS5552 in Adult Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 主要终点
- Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
研究概览
简要总结
The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.
详细描述
This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before.
The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days.
The secondary objectives include:
- To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
- To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
- To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics
A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with type 2 diabetes
- •Age: 18 to 65 years
- •BMI: 20 to 29 kg/m2
- •Mentally, physically and legally eligible to give informed consent.
- •Willingness to adhere to the protocol requirement.
排除标准
- •Subjects with type 1 diabetes
- •Episodes of hypoglycemia
- •Unstable cardiovascular diseases
- •Hepatic diseases
- •Kidney disease
- •Mental or central nervous system diseases
- •Clinical abnormal findings in ECG, labs and physical exams
研究组 & 干预措施
HMS5552 dose 1
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: HMS5552 (Drug)
HMS5552 dose 1
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: Placebo (Drug)
HMS5552 dose 2
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: HMS5552 (Drug)
HMS5552 dose 2
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: Placebo (Drug)
HMS5552 dose 3
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: HMS5552 (Drug)
HMS5552 dose 3
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: Placebo (Drug)
HMS5552 dose 4
HMS5552 25~400mg. Oral administration, once per day.
干预措施: HMS5552 (Drug)
HMS5552 dose 4
HMS5552 25~400mg. Oral administration, once per day.
干预措施: Placebo (Drug)
HMS5552 dose 5
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: HMS5552 (Drug)
HMS5552 dose 5
HMS5552 25~400mg. Oral administration, twice per day.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
时间窗: up to 15 days after study drug administration
次要结局
- The single dose and steady state pharmacokinetics (with food and fasting) of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2, CL/f, CLr/f, accumulation index and fluctuation index.(up to day 8 post-dose)
- Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial)(up to 6 hour post-dose)
- The single dose and steady state (fasting and postprandial) pharmacodynamic variables will include maximum absolute and percent change in plasma glucose level, AUC0-4, AUC0-16, AUC16-24, AUC0-24 hr of plasma glucose.(up to 4 hour post-dose and up to 24 hour post-dose)