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

Start Date10 Aug 2023

Sponsor / Collaborator

Xi'an Aolitai Pharmaceutical Technology Co., Ltd.

CTR20221902

/ CompletedPhase 1

一项随机、双盲、安慰剂对照、序贯平行设计、单次和多次递增剂量(SAD/MAD)评估口服MT2004在健康受试者中的安全性、耐受性、药代动力学研究

[Translation] A randomized, double-blind, placebo-controlled, sequential parallel design, single and multiple ascending dose (SAD/MAD) study to evaluate the safety, tolerability, and pharmacokinetics of oral MT2004 in healthy 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）。

[Translation]

Primary purpose: To evaluate the safety and tolerability of single and multiple ascending doses of oral MT2004; Secondary purpose: To evaluate the racial differences in the use of MT2004 by analyzing the pharmacokinetic characteristics of MT2004 and its metabolite MT2004-met1 (compared with the Phase I clinical trial completed in the United States).

Start Date26 Aug 2022

Sponsor / Collaborator

Xi'an Aolitai Pharmaceutical Technology Co., Ltd.

NCT04277910

/ CompletedPhase 1

A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, SAD/MAD Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MT2004

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.

Start Date09 Jan 2020

Sponsor / Collaborator

Xi'an Aolitai Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with MT-2004

100 Translational Medicine associated with MT-2004

100 Patents (Medical) associated with MT-2004

100 Deals associated with MT-2004

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cholestasis, Progressive Familial Intrahepatic 3	Phase 2	China	Xi'an Aolitai Pharmaceutical Technology Co., Ltd.	30 Nov 2023
Chemical and Drug Induced Liver Injury	Phase 2	China	Xi'an Aolitai Pharmaceutical Technology Co., Ltd.	10 Aug 2023
Cholestatic liver disease	Phase 2	China	Xi'an Aolitai Pharmaceutical Technology Co., Ltd.	10 Aug 2023
Metabolic Dysfunction Associated Steatohepatitis	Phase 1	United States	Shaanxi Micotech Pharmaceutical Technology Co., Ltd.	-
Metabolic Dysfunction Associated Steatohepatitis	Phase 1	China	Shaanxi Micotech Pharmaceutical Technology Co., Ltd.	-

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