KCT0002539招募中未知
A dose block-randomized, double blinded, placebo controlled, dose-escalation clinical trial to find the maximum tolerable dose after single oral dose of HL237 in healthy male subject
The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 56 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)(—)
- 性别
- Male
入选标准
- •1) A healthy adult male aged 20 years or older and 45 years old at the time of the screening test
- •2) Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
- •3) Proper contraception during the clinical trial period
- •4) After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement
排除标准
- •1) Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease
- •2) a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
- •3) a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives
- •4) a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
研究者
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