KCT0005647招募中未知
An open-label, single dose (Part 1) and multiple ascending dose (Part 2) phase I clinical trial to investigate the safety, tolerability and pharmacokinetics of NewGenNafamostat oral administration in healthy male subjects
ewGen Therapeutics0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- 19?(Year) 至 50?(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy adult male aged 19 to 50 years old at the time of screening test
- •2. A person who weighs more than 55.0 kg and less than 90.0 kg at the time of a screening test and has a BMI of more than 19.0 and less than 30.0 kg
- •? BMI (kg/m2) = weight (kg) / {height (m)}2
- •3. A person who decides to participate voluntarily and agrees in writing before the screening test after hearing and fully understanding the detailed description of this clinical trial
- •4. A person who the investigator has determined to be suitable for this screening test through physical examination, clinical laboratory examination, interview, etc
排除标准
- •1. A person who has or has a past history of diseases such as clinically significant hepatobiliary(such as severe liver disorders), kidneys (such as severe neuropathy), nervous systems, immune systems, respiratory systems, endocrine systems, blood and tumors, cardiovascular (heart failure, Torsades de points, etc.) and urinary systems and mental disorders.
- •2. A person who is hypersensitive or has a history of clinically significant hypersensitivity to Nafamostatmesilate, drugs including the same family, and other drugs (such as aspirin, antibiotics, etc.)
- •3. A person who has gastrointestinal diseases that may affect the safety and pharmacokinetic evaluation of clinical trial medications (gastric ulcer, gastritis, gastric cramps, gastrointestinal reflux disease, Crohn's disease, etc.) or has a history of related surgery (excluding simple appendectomy and hernia surgery)
- •4. A person who has the following results in a screening test:
- •1) A case that blood AST, ALT is >1.5 times the normal range upper limit
- •2) A case that total bilirubin is >1.5 times the normal range upper limit.
- •3) A case that blood CPK is >1.5 times the normal range upper limit
- •4) A case that eGFR (estimated Glomerular Filtration Rate) calculated from the MDRD (Modification of Diet in Renewal
- •Phase) formula < 90 mL/min/1.73m2
- •5) A case that QTc interval >450 ms is checked
- •6) A person who is positive for serum test (paroxic test, hepatitis B test, hepatitis C test, HIV test)
- •7) A person who, after a three-minute break, shows a corresponding figure of less than 90 mmHg or more than 150 mmHg of systolic blood pressure and less than 60 mmHg or more than 100 mmHg of dilatation blood pressure of vital signs measured at the left
- •5. A person who has a history of drug abuse or tested positive for abuse in urine screening tests
- •6. A person who has taken any ethical drug or oriental medicine within two weeks prior to the expected first dose date, or who has taken any over the counter drug(OTC drug) or health-functional food or vitamin supplements within one week (but may participate in clinical trials if other conditions are reasonable according to the investigator's judgment), or is expected to take such medication
- •7. A person who has taken a drug that induces and inhibits the drug's metabolic enzymes, such as barbithalide drugs, within one month prior to the expected first dose date
- •8. A person who participated in other clinical trials (including biological equivalence tests) within six months of the expected first dose date
- •9. A person who has donated whole blood within two months or donated apheresis blood within one month prior to the expected first dose date, or has received a blood transfusion within one month prior to the expected first dose date
- •10. A person who drinks continuously (above 21 units/week, 1 unit = 10 g of pure alcohol) or is unable to abstain from drinking for a period from three days prior to the expected first dose date to the last discharge
- •11. A person who is currently smoking (but may be selected as a subject if he/she stop smoking before three months) or who is unable to stop smoking for the period from three months prior to the expected date of first dose to the last discharge
- •12. A person who cannot refrain from consuming foods containing grapefruit during the period from three days prior to the expected first dose date to the last discharge
- •13. A person who has consistently ingested excessive caffeine (over 5
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