A dose block-randomized, double-blind, placebo controlled, single- and multipledosing, 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 male subjects

J2H Biotech0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年3月4日

试验速览

暂无简介。

•1) A healthy male adult within the range of 19 to 45 years old
•2) BMI=18.0~27.0kg/m2 (Body mass index, BMI)
•3) A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
•4) A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
•5) A subject who has voluntarily agreee to participate in the study

•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 subject who the investigator deems inappropriate for this clinical trial.

发起方

J2H Biotech