KCT0000968已完成未知
A Randomized, Double-blind, Placebo-controlled, Single-dosing, Dose-escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 After Continuous Intravenous Infusion in Healthy Male Volunteers
iNtRON Biotechnology0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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. Healthy male subject whose age is 20 ~ 45 at the time of screening visit.
- •2. Body weight of =50kg and <90kg, while within ±20% of the ideal body weight. [ideal body weight(kg) = {height(cm)-100}x 0.9]
- •3. Subject agreed to participate in the trial and to follow all of trial-related rules with a full understanding, after having a full account of the trial
排除标准
- •1. Present disease(s) or medical history(ies) which is(are) clinically significant on liver, heart, nervous system, respiratory system, hemato-oncology, cardiovascular or psychopathy.
- •2. Diagnosed or suspected infectious disease within 30 days in prior to the administration.
- •3. Clinically significantly allergic to drug(s) containing AI of N-Rephasin® SAL200 or to other drugs including aspirin and antibiotics, or has medical history(ies) on such allergy.
- •4. Already has taken other drug(s) containing AI of N-Rephasin® SAL200.
- •5. Positive for Antibody of N-Rephasin® SAL200.
- •6. SBP=90mmHg or DBP=50mmHg, otherwise, SBP=150mmHg or DBP=100mmHg in Vital sign which was measured after taking 3 minutes of resting in sitting position.
- •7. Has medical history of drug abuse or positive to drug abuse in urine drug screening.
- •8. Has taken any prescription drug(s) or herbal medicine(s) within 14 days prior to the administration, otherwise, any OTC(s) or vitamin(s) within 7 days prior to the administration(However, can participate in the study if investigator makes a decision that the subject can participate regardless the drug taken).
- •9. Has taken any other study drugs within 2 months prior to the administration.
- •10. Has donated blood(whole blood donation or component transfusion) within (2 months or 1 month, respectively) in prior to the administration, otherwise, has received blood transfusion within 1 month in prior to the administration.
- •11. Smoke at present or positive to metabolism of nicotine in urine test.
- •12. Drink regularly(over 21 units/week, 1 unit= 10 g of pure alcohol), otherwise, is not able to interrupt drinking and smoking in study period.
- •13. Investigator made a decision that the subject is not eligible based on results of laboratory test or other reason.
- •14. Not agree with contraception for 60days after the administration, otherwise, notification of pregnancy in case of his partner is pregnant for 90 days after the administration.
研究者
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