jRCT2071220064已完成不适用
SK-5307 Phase I (multiple-dose study in healthy adult male subjects)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 40age old not（—）
- 性别
- Male
入选标准
- •Subjects aged 18 years or older but less than 40 years (at the time of informed consent)
- •Subjects whose BMI (weight (kg)/[height (m)]2) is between 18.5 and 25.0 (at the time of screening test)
- •Subjects considered eligible for this study based on the results of screening examination by the investigator or sub-investigator.
- •Subjects who have the capacity to consent and whose written consent has been obtained from the subject
排除标准
- •Subjects with current medical history.
- •Subjects with a history of liver disease, renal disease, cardiovascular disease, hematological disease, endocrine system disease, digestive system disease, respiratory system disease, psychiatric or cranial nerve disease (including epilepsy), infectious disease that the investigator or sub-investigator judges to affect the safety of the subject or the evaluation of the investigational drug.
- •Subjects with clinically abnormalities in the screening or rest on the day of admission of 12-lead electrocardiogram in period I.
- •Subjects with a complication or a history of drug dependence or alcohol dependence.
- •Subjects with a complication or a history of drug hypersensitivity.
- •Subjects with a complication or a history of food allergy.
- •Subjects who had an average of 20 grams or more of alcohol per day.
- •Subjects who used any drug or supplement within 2 weeks prior to hospitalization in period I.
- •Subjects who had food or beverages containing grapefruit (juice or pulp) within 3 days prior to prior to hospitalization in period I.
- •Subjects who had ingested food or beverages containing St. John's wort (St. John's wort) within 1 week prior to hospitalization in period I.
- •Subjects who have donated 400 mL whole blood within 12 weeks prior to hospitalization in the first stage, 200 mL whole blood within 4 weeks, or blood component(plasma component, platelet component) within 2 weeks.
- •Subjects who had a positive result for HIV antigen/antibody, HBs antigen, or HCV antibody, or a positive reaction to syphilis serology or urine drug test at screening.
- •Subjects with a positive for SARS-CoV-2 nucleic acid amplification test on the day of admission.
- •Subjects with symptoms of suspected COVID-19 (novel coronavirus infection).
- •Subject who is in the opinion of the investigator or sub-investigator, unsuitable in any other way to participate in this study.
结局指标
主要结局
-
Safety, Pharmacokinetics, Pharmacodynamics
次要结局
未报告次要终点
研究者
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