NCT03056209已完成1 期
A Dose Block-randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation, Phase I Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of reported adverse events
研究概览
简要总结
The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19 - 45 years of age at the time of screening
- •Subjects weighing ≥55 and ≤90 kg with BMI between 18 and 27 kg/m2
- •Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
排除标准
- •History of clinically significant hepatic, renal, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular, psychiatric disease
- •History of disease or surgery of the gastrointestinal tract that could interfere with kinetics of the study drug. Simple hernia repair or appendectomy are excepted.
- •History of clinically significant or relevant allergy/hypersensitivity
- •Blood AST (SGOT), ALT (SGPT) >1.5 of upper limit
- •eGFR value of ≤90mL/min/1.73m2
- •Systolic blood pressure of <100 mmHg or >160 mmHg
- •Diastolic blood pressure of <60 mmHg or >100 mmHg
- •Any abnormalities in 12-lead ECG at screening visit
- •Subjects who showed positive result in drug abuse tests, or who has history of drug abuse within 60 days prior to the time of screening
- •Subjects who took prescribed medications or oriental medicine within 14 days or over-the-counter (OTC) medications or vitamins within 7 days prior to the dose of the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator)
- •Subjects who were administered any investigational products within 3 months from the first dose of the study drug
- •Subjects who have donated whole blood (60 days) or partial blood (30 days), or received blood transfusion
- •Subjects who have had alcohol consistently (>21units/week, 1unit=10 g of pure alcohol) or who is not able to stop drinking alcohol throughout the study period
- •Subjects who have smoked until 90 days prior to the study initiation or who are not able to stop smoking throughout the study period
- •Subjects who are not able to stop taking grapefruit/caffeine from 3 days prior to the first dose of the study drug throughout the study period
- •Subjects who plan for pregnancy during the study period or who are not able to use established contraceptive method
- •Subject who judged not eligible for study participation by investigator
研究组 & 干预措施
KL1333 50mg
Experimental
Group 2
干预措施: Placebo (Drug)
KL1333 100mg
Experimental
Group 3
干预措施: KL1333 100 mg (Drug)
KL1333 100mg
Experimental
Group 3
干预措施: Placebo (Drug)
KL1333 200mg
Experimental
Group 4
干预措施: KL1333 200 mg (Drug)
KL1333 200mg
Experimental
Group 4
干预措施: Placebo (Drug)
KL1333 25mg
Experimental
Group 1
干预措施: KL1333 25 mg (Drug)
KL1333 25mg
Experimental
Group 1
干预措施: Placebo (Drug)
KL1333 50mg
Experimental
Group 2
干预措施: KL1333 50 mg (Drug)
KL1333 400mg
Experimental
Group 5
干预措施: KL1333 400 mg (Drug)
KL1333 400mg
Experimental
Group 5
干预措施: Placebo (Drug)
KL1333 600mg
Experimental
Group 6
干预措施: KL1333 600 mg (Drug)
KL1333 600mg
Experimental
Group 6
干预措施: Placebo (Drug)
KL1333 800mg
Experimental
Group 7
干预措施: KL1333 800 mg (Drug)
KL1333 800mg
Experimental
Group 7
干预措施: Placebo (Drug)
结局指标
主要结局
Number of reported adverse events
时间窗: from day 1 to day 15
次要结局
- Maximum plasma concentration (Cmax) of KL1333(from day 1 to day 15)
- Area Under the Curve (AUC) of KL1333(from day 1 to day 15)
- Half-life (T1/2) of KL1333(from day 1 to day 15)
研究者
研究点 (1)
Loading locations...
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