jRCT2031230570已完成不适用
Phase I Clinical Study of JTE-052 new drug product - Dermal Safety Study -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 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
- Single Assignment
- 主要目的
- Other
- 盲法
- Single Blind
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •1.Healthy Japanese males aged from 20 to 45 years
- •2.Those with a body mass index (BMI) of 18.5 to less than 25.0
排除标准
- •1.Those who have skin conditions that may affect the evaluation in the study, e.g., eczema, dermatitis, pigmentation abnormality, inflammation caused by sunburn, injury, scar, and excessive hair growth, at the prospective application site
- •2.Those who have a history of contact dermatitis caused by dermatological drugs, adhesive plaster, tape, etc. mechanical urticaria, dermal hypersensitivity, or atopic dermatitis
- •3.Those to whom JTE-052 has been administered in the past
- •4.Those for whom the investigator judged it problematic to participate in the study
结局指标
主要结局
-
Potential for skin irritation
次要结局
未报告次要终点
研究者
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