jRCT2051240138已完成不适用
A Single/Multiple Dose Study of SSJG-009 (Phase I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sunstar Inc.
- 入组人数
- 9
- 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
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 40age old not（—）
- 性别
- Male
入选标准
- •Healthy Japanese adult males aged 20 to 40 years on the day of consent, who the investigator or subinvestigator considers to be in good physical health and be clinically normal based on a full-body examination, including medical history, blood pressure, and pulse rate.
- •Subjects with a BMI (body mass index) of 18.5 or more and less than 25.0
- •BMI (kg/m2) = weight (kg)/[height (m)]2
- •Subjects have been fully informed about the investigational drug and the outline of the clinical trial, volunteered, and given written consent to participate in the clinical trial.
排除标准
- •(1) Subjects with a health condition that may affect the absorption, distribution, metabolism, and excretion of the investigational drug, or a history of such a condition (e.g., history of resection of the liver, kidneys, gallbladder, or digestive tract).
- •(2) Subjects with a serious cardiac, vascular, renal, liver, digestive, endocrine, nervous, skin, metabolic, or immune disease, or a history of such a disease.
- •(3) Subjects with blood abnormalities (aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia, etc.), or a history of such an abnormality.
- •(4) Subjects with a tendency to bleed.
- •(5) Subjects with hypertension.
- •(6) Subjects with a peptic ulcer, or a history of such an abnormality.
- •(7) Subjects with aspirin-induced asthma, or a history of such an abnormality.
- •(8) Subjects with a history of drug hypersensitivity, asthma, urticaria, or other significant allergic predisposition.
- •(9)Subjects with a history of hypersensitivity to any ingredient (including additives) of this product.
- •(10) Subjects with or a history of hypersensitivity to influenza-related encephalopathy or encephalitis.
- •(11) Subjects currently receiving or who may be receiving triamterene.
- •(12) Subjects with clinical abnormalities in 12-lead resting electrocardiograms or significant prolongation of the QT/QTc interval.
- •(13) Subjects with positive results for hepatitis B, hepatitis C, HIV, or syphilis.
- •(14) Subjects who are determined by the principal investigator (subinvestigator) to be ineligible to participate in this clinical trial in a screening test.
- •(15) Subjects who are otherwise determined by the principal investigator (subinvestigator) to be ineligible to participate in this clinical trial.
结局指标
主要结局
-
Safety, Pharmacokinetics
次要结局
未报告次要终点
研究者
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