JPRN-jRCT2071230110招募中1 期
Skin Safety Study of CB-03-01 Cream in Healthy Volunteers
Toida Tsuneyuki0 个研究点目标入组 30 人开始时间: 2024年1月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 65age old(—)
- 性别
- Male
入选标准
- •Who are able to understand and comply with the content of the study, and whose written informed consent has been obtained by when any study-related procedures begin.
- •-Aged 18 to < 65 years old (at informed consent).
- •-Body mass index (BMI) is 18.5 kg/m2 or more and less than 25.0 kg/m2 (at screening tests).
排除标准
- •-Individuals with a medical history or complications including liver disease, renal disease, heart and other cardiovascular diseases, digestive disease, blood disease, and skin disease ,etc, which are considered inappropriate for participation in the study.
- •-Individuals with a medical history or complications of contact dermatitis including tape dermatitis, and mechanical urticaria.
- •-Individuals with a medical history or complications of skin hypersensitivity to topical agents, cosmetic, or quasi-drugs.
- •-Individuals with a medical history or complications of hypersensitivity to CB-03-01 or its components.
- •-Individuals with abnormal findings (e.g., eczema/dermatitis, dyschromatosis, inflammation by sunburn, wounds injury, and scars) on the planned application site of the study drug (at screening and prior to the study drug application on Day 1).
- •-Individuals who used any drugs (and/or vaccines) including over-the-counter drugs within 7 days prior to the study drug application or who need to use any drugs (and/or vaccines) including over-the-counter drugs during the study period.
- •-Individuals who the Investigator considers ineligible to be subjects.
研究者
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