KCT0008007已完成未知
A Double-Blind, Placebo Controlled, Single Dosing, Dose-Escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Characteristics of J2H-1702 (Nonalcoholic Steatohepatitis Treatment Candidate) after Oral Administration in Healthy Female Subjects
J2H Biotech0 个研究点目标入组 16 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
- 16
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 45(Year)（—）
- 性别
- Female
入选标准
- •1) Healthy females aged = 19 and = 45 years
- •2) Subjects with a body mass index (BMI) = 18.0 to = 27.0 kg/m2
- •3) Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests
- •4) Agree to use dual contraceptive methods and not to donate eggs
- •5) Voluntarily agree to participate in the study
排除标准
- •1) A subject who had or has the disease corresponding to clinically significant liver, etc.
- •2) A subject with a history of gastrointestinal diseases or surgery
- •3) A subject who has a history of clinically significant hypersensitivity to drugs containing 11ß-HSD1 inhibitor
- •4) A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ·galactose malabsorptivity, etc.
- •5) One who has drug abuse and one who is positive response in urine drug screening tests
- •6) A subject with abnormal vital signs at the screening visit
- •7) A subject who has participated in another clinical trial or bioequivalence test
- •8) A subject who donated whole blood or the ingredient, or received blood transfusion
- •9) A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
- •10) A subject who consumes grapefruit/caffeine-containing food
- •11) A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
- •12) High caffeine intaker, high alcohol intaker or excessive smoker
- •13) A subject who cannot eat meals provided by the Clinical Trial institution.
- •14) A subject who participated in this trial and were administered the investigational product.
- •15) A subject who is positive for serum test
- •16) A pregnanct or breast-feeding subject
- •17) A subject who the investigator deems inappropriate for this clinical trial
研究者
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