Xi'an Aolitai Pharmaceutical Technology Co., Ltd.

The goal of this randomized, double-blind, placebo controlled, Multicenter Phase II clinical trial is to initially evaluate the Safety and Efficacy of MT2004 Capsule in Cholestatic and Mixed drug induced liver injury (DILI) subjects.
The main questions it aims to answer are:
The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects
The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects
The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects

主要目的：评价口服单次和多次递增剂量MT2004的安全性及耐受性； 次要目的：通过分析MT2004及其代谢物MT2004-met1的药代动力学特征，评价MT2004用药的人种差异（与美国所完成的I期临床试验比较）。

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of MT2004 following oral single and multiple ascending dose administration.