A Dose Block-randomized, Double-blind, Placebo Controlled, Single and Multiple-dosing, Dose-escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, PK/PD of J2H-1702 After Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
- Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
- Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial
详细描述
Subjects in all dose groups will be randomized to the study group (J2H-1702 group) and the control group (Placebo group) in a 8:2 ratio. Adverse event (AE) collection, physical examination, vital signs, ECG, clinical laboratory tests, etc. will be performed to assess the safety and tolerability, and blood and urine sampling will be performed to assess the PK/PD characteristics. In addition, blood sampling for mass cytometry (multiple administration study) and baseline fibroscan will be performed for the exploratory evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male adult within the range of 19 to 45 years old
- •BMI=18.0~27.0kg/m2 (Body mass index, BMI)
- •A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
- •A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
- •A subject who has voluntarily agree to participate in the study
排除标准
- •A subject who had or has the disease corresponding to clinically significant liver, etc.
- •A subject with a history of gastrointestinal diseases or surgery
- •A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
- •A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
- •One who has drug abuse and one who is positive response in urine drug screening tests
- •A subject with abnormal vital signs at the screening visit
- •A subject who has participated in another clinical trial or bioequivalence test
- •A subject who donated whole blood or the ingredient, or received blood transfusion
- •A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
- •A subject who consumes grapefruit/caffeine-containing food
- •A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
- •High caffeine intaker, high alcohol intaker or excessive smoker
- •A subject who cannot eat meals provided by the Clinical Trial institution.
- •A subject who participated in this trial and were administered the investigational product.
- •A subject who is positive for serum test
- •A subject who the investigator deems inappropriate for this clinical trial.
研究组 & 干预措施
Single administration Amg dose Group
干预措施: Single administration Amg dose Group (Drug)
Single administration Bmg dose Group
干预措施: Single administration Bmg dose Group (Drug)
Single administration Cmg dose Group
干预措施: Single administration Cmg dose Group (Drug)
Single administration Dmg dose Group
干预措施: Single administration Dmg dose Group (Drug)
Single administration Emg dose Group
干预措施: Single administration Emg dose Group (Drug)
Single administration Amg dose Group-Placebo
干预措施: Single administration Amg dose Group-Placebo (Drug)
Single administration Bmg dose Group-Placebo
干预措施: Single administration Bmg dose Group-Placebo (Drug)
Single administration Cmg dose Group-Placebo
干预措施: Single administration Cmg dose Group-Placebo (Drug)
Single administration Dmg dose Group-Placebo
干预措施: Single administration Dmg dose Group-Placebo (Drug)
Single administration Emg dose Group-Placebo
干预措施: Single administration Emg dose Group-Placebo (Drug)
Multiple administration Amg dose group
干预措施: Multiple administration Amg dose group (Drug)
Multiple administration Bmg dose group
干预措施: Multiple administration Bmg dose group (Drug)
Multiple administration Cmg dose group
干预措施: Multiple administration Cmg dose group (Drug)
Multiple administration Dmg dose group
干预措施: Multiple administration Dmg dose group (Drug)
Multiple administration Emg dose group
干预措施: Multiple administration Emg dose group (Drug)
Multiple administration Amg dose group - Placebo
干预措施: Multiple administration Amg dose group - Placebo (Drug)
Multiple administration Bmg dose group - Placebo
干预措施: Multiple administration Bmg dose group - Placebo (Drug)
Multiple administration Cmg dose group - Placebo
干预措施: Multiple administration Cmg dose group - Placebo (Drug)
Multiple administration Dmg dose group - Placebo
干预措施: Multiple administration Dmg dose group - Placebo (Drug)
Multiple administration Emg dose group - Placebo
干预措施: Multiple administration Emg dose group - Placebo (Drug)
结局指标
主要结局
Cmax
时间窗: 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours (After IP administration)
Pharmacokinetics
Emax
时间窗: -1day 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours, 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours (After IP administration)
Pharmacodynamics
次要结局
未报告次要终点