Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      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 .
    

Detailed description: 
      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.
    

Intervention name(s): ZSP1601 25 mg; Placebo 25mg; ZSP1601 50 mg; Placebo 50 mg; ZSP1601 100 mg; Placebo 100 mg; ZSP1601 175 mg; Placebo 175 mg; ZSP1601 275 mg; Placebo 275 mg; ZSP1601 350 mg; Placebo 350mg; ZSP1601 100 mg; Placebo 100mg; ZSP1601 50 mg; Placebo 50 mg; ZSP1601 100 mg; Placebo 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ZSP1601 tablet administered orally once daily under fasted condition; Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition; ZSP1601 tablet administered orally once daily under fasted condition; Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition; ZSP1601 tablets administered orally once daily in the fasting state; Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state; ZSP1601 tablets administerekd orally once daily under fasted condition; Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition; ZSP1601 tablets administered orally once daily in the fasting state; Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state; ZSP1601 tablets administered orally once daily under fasted condition; Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition; ZSP1601 tablets administered orally once daily under fasted or fed condition; Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition; ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).; Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).; ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).; Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment