A Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Orally Administered DA-7503 After Single and Multiple Ascending Dose Regimens in Healthy Adult and Elderly Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of DA-7503 single dose oral administration
研究概览
简要总结
This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers(Age: 19~55 years, 65~85 years)
- •Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²
排除标准
- •Clinically significant Medical History
- •Allergy or Drug hypersensitivity
- •AST, ALT, Total billurbin > Upper Normal Range*1.5, eGFR<60mL/min/1.73m²
- •Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
- •Heavy smoker(more than 10 cigarettes/day)
- •Heavy caffeine intake(more than 5 units/day)
- •Heavy alcohol intake(more than 210g/week)
研究组 & 干预措施
[Multiple dose] Placebo
2 subjects in each Cohort(Cohort 1-5)
干预措施: Placebo Multiple dose (Drug)
[Single dose] DA-7503
6 subjects in each Cohort(Cohort 1-6)
干预措施: DA-7503 Single dose (Drug)
[Single dose] Placebo
2 subjects in each Cohort(Cohort 1-6)
干预措施: Placebo Single dose (Drug)
[Multiple dose] DA-7503
6 subjects in each Cohort(Cohort 1-5)
干预措施: DA-7503 Multiple dose (Drug)
结局指标
主要结局
Pharmacokinetics of DA-7503 single dose oral administration
时间窗: 5 days
Peak Plasma Concentration of DA-7503 (Cmax)
Pharmacokinetics of DA-7503 multiple dose oral administration
时间窗: 11 days
Peak Plasma Concentration of DA-7503 (Cmax)
次要结局
未报告次要终点