跳至主要内容
临床试验/jRCT2031230626
jRCT2031230626已完成不适用

A Phase I, skin safety study with SKE-18 1% cream in healthy Japanese participants

Sato Pharmaceutical Co., Ltd.0 个研究点目标入组 25 人开始时间: 2024年3月28日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
25
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
18age old over 至 40age old under(—)
性别
Male

入选标准

  • Healthy Japanese adult males aged 18 to 40 years at the time of signing the Informed Consent Form
  • Subjects with BMI (body mass index) of >= 18.5 to < 25.0 at screening
  • Subjects who are considered by the investigator as acceptable for inclusion in the study as judged from the results of observation and inspection upon screening and admission
  • 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

  • Subject with a medical history of drug allergy
  • Subjects with a medical history of food allergy
  • Subjects with a medical history (heart, liver, kidney, lung, blood diseases, etc.) that is considered ineligible for the study
  • Subjects with a medical history of contact dermatitis, such as adhesive tape dermatitis, or mechanical urticaria
  • Subjects with a medical history of photosensitivity
  • Subjects considered ineligible for the study by the investigator

结局指标

主要结局

-

Safety

次要结局

未报告次要终点

研究者

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