NCT03713892Unknown1 期
Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Cmax of CKD-504
研究概览
简要总结
To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
- •Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
- •Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
- •Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
排除标准
- •Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
- •Subjects with a history of drug abuse or a positive urine screening for drug abuse.
- •Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
- •Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
- •Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
研究组 & 干预措施
CKD-504
Experimental
investigational Drug
干预措施: CKD-504 (Drug)
Placebo
Placebo Comparator
investigational Drug
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax of CKD-504
时间窗: Day1, Day2, Day3, Day4
Peak Plasma Concentration (Cmax) of CKD-504
AUC of CKD-504
时间窗: Day1, Day2, Day3, Day4
Area under the plasma concentration versus time curve (AUC) of CKD-504
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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