KCT0008410已完成Unknown
A randomized, single-blind, placebo-controlled, single/multiple dose, dose escalation, phase 1 clinical trial to evaluate safety, tolerability and pharmacokinetic characteristics of CKR-051 after transdermal administration in healthy male subjects
CK Regeon0 个研究点目标入组 52 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 52
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
- 19(Year) 至 60(Year)（—）
- 性别
- Male
入选标准
- •Healthy adult male aged 19 to 60 years old at the time of screening.
- •- Those who weigh not less than 55.0 kg and not more than 90.0 kg and have a BMI of not less than 19.0 kg/m2 and not more than 29.0 kg/m2 at the time of screening.
- •- Healthy adult male who has heard and has voluntarily decided to participate and has agreed in writing to informed consent form.
- •- A person who is suitable for this clinical trial when judging by a investigator through a physical examination, clinical laboratory examination, questionnaire, etc.
排除标准
- •- A person who has or has a history of clinically significant sclerosis, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system, urinary system, psychiatric system, dermatological disease, etc.
- •- A person who has an hypersensitivity to a drug (aspirin, antibiotics, etc.) or has a history of clinically significant hypersensitivity.
- •- A person who has a history of drug abuse or has tested positive for urine screening (cnabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine, cotinine).
- •- A person who has taken a ethical drug or herbal medicine within two weeks before the first application date, or has taken a over-the-counter drug or health functional food or vitamin preparation within one week (however, other conditions are reasonable at the discretion of the investigator).
- •- A person who has taken drug-metabolizing enzyme inducing or inhibiting drugs such as barbiturates within 1 month before the expected first application date
- •- A person who participated in other clinical trials and received investigational drugs within 6 months of the expected first application date.
- •- Whole blood donation or component blood donation within 1 month before the expected first application date, or blood transfusion within 1 month before the expected first application date
- •- A person who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot abstain from drinking during the clinical trial period or until the end of the visit.
- •- Current smokers (However, if you quit smoking 3 months before the expected first application date, you can be selected).
- •- Those who cannot abstain from eating food containing grapefruit (grapefruit) during the period from 24 hours before admission to the clinical trial period and end visit.
- •- Those who consistently consumed excessive caffeine (> 5 units/day) or caffeine/caffeine-containing food (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee milk, nutritional tonic drinks, etc.) during the clinical trial period and end visit.
- •- Those who, for at least 90 days from the last application of the investigational product, have not been able to use an appropriate medically recognized double method of contraception or a medically acceptable method of contraception, and who will not donate sperm until that period those who agree to
- •- Those who are judged by the investigator to be unfit to participate in clinical trial due to other reasons.
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