Nonalcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMM-H014 Sand the Effects of Food on Pharmacokinetics in Healthy Subjects
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.
The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose (SAD) part, multiple ascending dose (MAD) part and food effect (FE) part. SAD and MAD parts adopt "sentinel method "which2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort). Subjects in SAD will receive 12.5,37.5,75, 125, 225, 275, 325mg (Cohort 1-4 and Cohort 6-8) once daily respectively. Subjects in MAD will receive 37.5, 75, 125, 175, 225mg (Cohort 9 - Cohort 13) once daily for 7days respectively. FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts "sentinel method ".The treatment in food effect consists of 2 periods, and subjects will receive175mg(SAD Cohort 5) on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods. To monitor AEs, record abnormalities (12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of IMM-H014. ;
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