drugset / Trial / NCT06019936

A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects

NCT06019936 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2023-08-10
Primary completion
2025-08-10
Completion
2025-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MT2004 Small molecule 25 mg Oral