跳至主要内容
临床试验/JPRN-jRCT2031230626
JPRN-jRCT2031230626尚未招募1 期

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

Kasumi Sanpei0 个研究点目标入组 25 人开始时间: 2024年2月8日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
25

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 <= 40age old(—)
性别
Male

入选标准

  • 1. Healthy Japanese adult males aged 18 to 40 years at the time of signing the Informed Consent Form
  • 2. Subjects with BMI (body mass index) of >= 18.5 to < 25.0 at screening
  • 3. 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
  • 4. 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

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

研究者

发起方
Kasumi Sanpei

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