Drug-Induced Liver Injury Clinical Trial
Official title:
A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in Treatment of Cholestatic and Mixed Drug Induced Liver Injury (DILI)
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: 1. The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects 2. The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects 3. The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects
Xi'An Aolitai Pharmaceutical Technology Co Ltd is developing MT2004, a novel investigational synthetic small molecule farnesoid X receptor (FXR) agonist targeted to the liver. The MT2004 was designed as the prodrug and the metabolites MT2004-met1 of MT2004 will act to the FXR receptor to regulate a series of genes expression. It also plays an important role in the metabolism of bile acids, lipids and sugars. 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 whole study will be divied to three stages including screening period (14 Days before the treatment), treatment period (the participants will be randomized to receive MT2004, or placebo orally (BID), for 12 weeks) and follow-up period. The study aims to recruit total of 80 subjects with Cholestatic and Mixed DILI, in which 12 of subjects will be firstly enrolled and allocated to the MT2004 group (Dose level: 25mg) as well as control group with the proportion of 2:1 by using the stratified randomization method. During the whole study, the adjustment of the subjects amount, the dose level as well as randomization proportion will based on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID. The placebo will be used in this study, and the researchers will compare the placebo and test article to see the safety and efficacy. ;
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