A Dose Blocked-randomized, Double-blind, Active and Placebo Controlled, Single and Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Pharmacodynamic Measurement
研究概览
简要总结
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
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
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 20 and 50 years at screening
- •Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI (kg/m2) = body weight (kg)/ {height (m)}
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
- •Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
排除标准
- 未提供
研究组 & 干预措施
LC23-1306
experimental drug
干预措施: LC23-1306 (Drug)
placebo
LC23-1306 placebo
干预措施: placebo (Drug)
Ticagrelor
active comparator
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Pharmacodynamic Measurement
时间窗: 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study
Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test. \* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section.
Platelet Aggregation Test, Bleeding Test
时间窗: pre-dose, up to 1 day post-dose
Adverse Events of LC23-1306
时间窗: 7 days (plus or minus 1 day)
次要结局
- AUC(pre-dose, up to 3 days post-dose)