jRCT2031220073已完成不适用
A Phase I, Single-dose Study with SB206 in Healthy Japanese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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
- Single Blind
入排标准
- 年龄范围
- 20age old over 至 40age old under（—）
- 性别
- Male
入选标准
- •Healthy Japanese adult males aged 20 to 40 years at the time of obtaining written informed consent
- •Subjects with a body mass index (BMI) of 18.5 to 25.0 at screening
- •Subjects who are considered by the investigator or subinvestigator as acceptable for inclusion in the study as judged from the results of observation and examination upon screening and hospitalization
- •Subjects who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent
排除标准
- •Subjects with a history of drug allergy
- •Subjects with a history of food allergy
- •Subjects with a history of contact dermatitis, such as adhesive tape dermatitis, or mechanical urticaria
- •Subjects considered ineligible for the study by the investigator or subinvestigator
结局指标
主要结局
-
Skin irritation
次要结局
未报告次要终点
研究者
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