NCT07691242尚未招募1 期
A Phase 1 Clinical Trial to Evaluate the Safety, the Pharmacokinetics and Pharmacodynamics After Multiple Administration of DW4421 in Healthy Adult Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration
研究概览
简要总结
Multiple Ascending Dose of DW4421, phase I
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
- •Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
排除标准
- •Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
结局指标
主要结局
AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration
时间窗: Day 7
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Cmax of DW4421 following multiple oral administration
时间窗: Day 7
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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