A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0
研究概览
简要总结
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
详细描述
This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and 8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be observed for 3 days.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Ages between 18 and 45 years
- •BMI Index between 19 and 25 (BMI=weight/height2)
- •Normal previous history and physical exam
- •No drug and alcohol abuse
- •No illness in 4 weeks and no drug therapy in 2 weeks
- •No blood donation or subject not sampled in 3 months
- •Consistent and correct use of recommended methods of birth control for men and women
- •Good compliance with study protocol
- •Understand and agree to sign a consent form
排除标准
- •Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV
- •Abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound of gallbladder, spleen and kidney, AFP ,and CEA
- •Positive for anti-Pre-S1 antibody
- •Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of ovaries/uterus proliferative diseases or breast mass
- •Unable to quit smoking in trial
- •Subject with little chance of enrollment (i.e. the weak)
- •Subject not suitable to join the trial under other circumstances judged by investigator.
研究组 & 干预措施
Hepalatide
Hepalatide 4.2mg, 6.3mg and 8.4mg
干预措施: Hepalatide (Drug)
Placebo
Placebo 4.2mg, 6.3mg and 8.4mg
干预措施: Placebo (Drug)
结局指标
主要结局
Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0
时间窗: 6 months
次要结局
- Maximum Plasma Concentration (Cmax)(6 months)
- Area under the plasma concentration versus time curve (AUC)(6 months)
- half-time(6 months)
- apparent volume of distribution(6 months)