Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 19 to 50 years
- •Body weight 55 to 90 kg and BMI 18.0 to 27.0
- •Voluntarily signed the informed consent form
- •Eligible according to the screening test results
- •Available to follow up after drop-out
排除标准
- •Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
- •Hypersensitivity to donepezil, piperidine derivatives and other drugs
- •SBP <100 mmHg or >150 mmHg, or DBP <60 mmHg or >100 mmHg
- •Skin and muscle disorders or history of surgery at the injection site
- •AST or ALT >1.5xULN; QT/QTcB interval >450 ms
- •History or positive result of drug abuse
- •Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week
- •Participated in other clinical trials within 3 months
- •Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
- •Alcohol consumption >21 units/week
- •Smoked >10 cigarettes/day within 3 months
- •Caffeine-containing foods
- •Not eligible due to other reasons at the investigator's discretion
研究组 & 干预措施
Donepezil 35 mg
Donepezil 35 mg or placebo
干预措施: DKF-310 (Drug)
Donepezil 35 mg
Donepezil 35 mg or placebo
干预措施: Placebo (Drug)
Donepezil 70 mg
Donepezil 70 mg or placebo
干预措施: DKF-310 (Drug)
Donepezil 70 mg
Donepezil 70 mg or placebo
干预措施: Placebo (Drug)
Donepezil140 mg
Donepezil 140 mg or placebo
干预措施: DKF-310 (Drug)
Donepezil140 mg
Donepezil 140 mg or placebo
干预措施: Placebo (Drug)
Donepezil 210 mg
Donepezil 210 mg or placebo
干预措施: DKF-310 (Drug)
Donepezil 210 mg
Donepezil 210 mg or placebo
干预措施: Placebo (Drug)
Donepezil 280 mg
Donepezil 280 mg or placebo
干预措施: DKF-310 (Drug)
Donepezil 280 mg
Donepezil 280 mg or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AUC
时间窗: 1056h
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
Cmax
时间窗: 1056h
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
次要结局
未报告次要终点