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

NCT06019936 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-08-31

No results posted yet for this study

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

Conditions

  • Drug-Induced Liver Injury
  • Cholestatic Liver Injury
  • Mixed Liver Injury

Interventions

DRUG

MT2004 Capsule

The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.

DRUG

MT2004 Capsule Placebo

The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 Capsule Placebo (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.

Sponsors & Collaborators

  • Xi'An Aolitai Pharmaceutical Technology Co Ltd

    lead INDUSTRY

Principal Investigators

  • YiMin Mao, Master · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2025-08-10
Completion
2025-10-10
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019936 on ClinicalTrials.gov