Nonalcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase 1 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1601 and the Effect of Food on ZSP1601 Pharmacokinetics in Chinese Healthy Subjects.
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 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 ZSP1601 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 postprandial pharmacokinetics part.The
primary aims of the study as below:
Evaluating the safety and tolerance of single and multiple dose of ZSP1601 in healthy
volunteers.
Evaluating the fasting and postprandial pharmacokinetic parameters of ZSP1601 in healthy
volunteers.
Eligible participants will be admitted to the trial center on Day -1. Subjects will be
randomly assigned to either experimental groups or placebo groups, according to a
randomisation schedule in a (4:1) ratio (8 in per experimental group). Subjects in SAD will
receive 25、50、100、175、275、350 mg once daily respectively.Each dose will be administrated
after assurance of safety for the former dose. Subjects in MAD will receive 50 or 100 mg once
daily for 14days respectively.The treatment in food effect consists of 2 periods,and subjects
will receive 100mg 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
ZSP1601.
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