KCT0008891已完成Unknown
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple- Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral VVZ-2471 in Healthy Male Volunteers
Vivozon0 个研究点目标入组 87 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 87
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 50(Year)（—）
- 性别
- Male
入选标准
- •1. Subjects who agree to participate in this study willingly and sign the written informed consent.
- •2. Healthy male subject aged from 19 to 50 years old
- •3. Weight from 55 kg to 90 kg with BMI range 18~27 /m2
- •4. Subjects who are deemed healthy when performing eligibility assessment (medical history, physical examinations, vital signs, ECG, blood chemistry, hematology, urine test)
- •5. Subjects who agree to maintain abstinence or to follow the medically acceptable method of contraception until the end of the study or infertile, and who are not willing to donate the sperms within 100 days after the study termination.
排除标准
- •1. Subjects with history of any illness or any clinical current conditions in liver (including viral hepatitis etc.), kidney, nervous system, respiratory system, endocrine system, and immune system. History of any illness or any clinical current conditions in blood, neoplastic disease, cardiovascular disease, neurological diseases including patients with or had a history of psychiatric diseases (mood disorders, OCD, schizophrenia etc).
- •2. Subjects who have experienced surgery involving gastrointestinal surgery (including but not limited to cholecystectomy, appendectomy, simple hernia repair) that may interfere with the pharmacokinetic properties of the investigational drug or subjects who has gastrointestinal diseases (Crohn's disease, ulcer, chronic or acute pancreatitis)
- •3. Subjects with a history of allergy, hypersensitivity or clinically significant hypersensitivity reactions to the investigational products (IP) or medicinal products containing any similar ingredients to IP and any other medications such as aspirin and antibiotics etc,.
- •4. Subjects showing ECG results of QTc > 430 msec, PR interval > 210 msec or QRS interval > 120 msec, and those who presents with other clinically significant findings.
- •5. Subjects who show the following results from the laboratory test
- •? ALT and/or AST > 1.5 times upper limit of normal
- •? BUN , Cr > 1. 5 times upper limit of normal
- •6. Subjects showing vital signs of systolic blood pressure of >150 mmHg or < 90 mmHg; diastolic blood pressure of > 95 mmHg or <60 mmHg.
- •7. Subjects who have history of drug abuse or who show positive results in urine test or positive breath alcohol test
- •8. Subjects who have taken any prescribed medicine, herbal supplement, or natural extract-based medicine within 2 weeks before the first-dosing; Subjects who have taken any OTC or vitamin supplement, dietary supplement ( St John’s wort, ginkgo leaf extract, garlic supplement, grapefruit or grapefruit juice, Seville orange, etc.), except that an investigator can judge the subject can participate in if all other conditions meet study conditions.
- •9. Subjects who have participated in another clinical trial and have taken IP within 6 months before the date of first administration of this study
- •10. Subjects who have donated whole blood within 2 months or blood component transfusion within 1 month before the first administration, or have accepted blood donation within 1 month before the first administration of IP.
- •11. Subjects who continuously drink alcohol (exceeding 21 units/ week, 1 unit equals 10 g of pure alcohol) or who smoke more than 40 cigarettes per day, or subjects who could not keep abstinence
- •12. Subjects who consumed caffeinated drinks [coffee, tea, (black tea, green tea etc,.), soft drinks, milk coffee, nutritional tonic drinks etc] 24 hours before hospitalization until to be discharged, or those who could not stop.
- •13. Subjects who are judged to be inappropriate to participate; difficulty participating and complying to the guidelines and/or follow-up investigations during the trials in the clinical trial due to medical, psychological, social, and geographical conditions.
- •14. Subjects who are judged to be ineligible for the participation in the clinical trial by Investigator due to other reasons.
研究者
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