Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- t1/2 of Donepezil
研究概览
简要总结
The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
详细描述
The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese healthy subjects, male or female
- •between the ages of 20 and 60 years
- •A body mass index (BMI), calculated as weight in kg/(height in m)², from 19 to 28 kg/m², and female weight≥45kg, male weight≥50kg
- •Able to provide written informed consent forms
排除标准
- •Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
- •Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >90mmHg
- •ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"
- •Clinically significant ECG abnormalities in screening or baseline, such as male QTc interval ≥450ms and female QTc interval ≥470ms, and were considered inappropriate for inclusion by the researchers
- •Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
- •History or presence of drug or alcohol abuse
- •Positive pregnancy test result, or plan to be pregnant if female
- •An unwillingness or inability to comply with food and beverage restrictions within 24 hours prior to dosing
- •Participation in any other investigational drug trial within 30 days prior to screening.
研究组 & 干预措施
experimental group 1
HHT201 17mg injection
干预措施: Donepezil Pamoate for Injection 17mg (Drug)
experimental group 2
HHT201 34mg injection
干预措施: Donepezil Pamoate for Injection 34mg (Drug)
experimental group 3
Donepezil Hydrochloride oral tablet 5mg
干预措施: Donepezil Hydrochloride 5mg (Drug)
结局指标
主要结局
t1/2 of Donepezil
时间窗: Blood samples collected over a 35 days period
The time when the concentraion of the drug eliminated to half of the initial.
Cmax of Donepezil
时间窗: Blood samples collected over a 35 days period
Maximum observed concentration of drug substance in plasma.
Tmax of Donepezil
时间窗: Blood samples collected over a 35 days period
Time when the maximum concentration is acheived
AUClast of Donepezil
时间窗: Blood samples collected over a 35 days period
Area under the concentration-time curve from time zero to time of last measurable concentration.
AUC0-∞ of Donepezil
时间窗: Blood samples collected over a 35 days period
Area under the concentration-time curve from time zero to infinity.
次要结局
未报告次要终点