Nonalcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) of XZP-5610 Tablets Following Single- and Multiple-ascending Doses (SAD/MAD) and Food Effects in Healthy Subjects.
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.
Part A and Part B studies were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single and multiple oral doses of XZP-5610 tablets in healthy adult subjects, and exploring preliminary food effects (non-high-fat meals) in the Part B study. Part C is a single-center, randomized, open, 2×2 crossover design designed to assess the foodeffects on PK of a single oral dose of XZP-5610 tablets in healthy adult subjects. ;
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