KCT0005915已完成未知
A randomized, open-label, single and multiple ascending dose phase 1 clinical trial to investigate the pharmacokinetic and tolerability of AST-001 administration in healthy subjects
Astrogen0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 55(Year)（—）
- 性别
- Male
入选标准
- •1. Helthy male between the ages of 19 and 55 years at the time of screening
- •2. 50~90 kg of body weight and 18.0~29.0 kg/m2 of BMI
- •3. Judged to be eligible for enrollment by the physician according to physical examination, history laboratory tests
- •4. Judged to be eligible for enrollment by laboratory test result according to protocol
- •5. Decided to participate in the clinical trial voluntarily, and provided written consent to follow the clinical trial guidelines
排除标准
- •1. Has a current or past history of a clinically significant disorder in the cardiovascular, respiratory, liver, kidney, neurological, endocrinal, hemato-oncological, psychological, urological systems
- •2. Has a current or past history of gastrointestinal disease or has a history of surgery that can influence in evaluating the safety and pharmacokinetic of the study drug
- •3. Has a history of hypersensitivity to AST-001, drugs containing a similar substance, or other drugs or a history of clinically significant hypersensitive reaction
- •4. Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
- •5. Has a current or past history of a clinically significant muscle disease
- •6. At screening, systolic BP <100mmHg or >150mmHg, diastolic BP <70mmHg or >100mmHg
- •7. At screening laboratory tests,
- •- AST, ALT, r-GT > values more than 2 times the upper limits of normal
- •- Total bilirubin > 2.0 mg/dL
- •- CK > values more tnan 2.5 times the upper limits of normal
- •- eGFR < 60 mL/min/1.73 m2
- •8. Heavy drinker(more than 21 units/week of alcohol) or cannot stop alcohol drinking for the study period
- •9. Heavy smoker(>10 cigarttes/day) or cannot stop smoking for the admisson period
- •10. Has donated whole blood within 60 days of study drug administration, apheresis within 30 days of study drug administration or has received transfusion within 30 days of study drug administration
- •11. Has taken any prescription medicine, herbal medicine within 14 days of study drug administration, or any over-the-counter drugs, nutritional agents including amino acids within 7 days of study drug administration
- •12. Has taken drugs that may induce or suppress drug metabolic enzymes, such as barbiturates within 30 days of study drug administration
- •13. Has a history of drug abuse or has positive urine screening results for drug abuse
- •14. Has ingested food products that may affect drug absorption, distribution, metabolism or excretion within 7 days of study drug administration
- •15. Has taken other clinical trial drugs within 6 months of the study drug administration
- •16. Has a clinically significant abnormal results in screening laboratory tests
- •17. Judged to be ineligible by the study investigator for other reasons
研究者
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