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最高研发阶段临床2期 |
首次获批国家/地区- |
首次获批日期- |
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:
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
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
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）。
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.
100 项与 西安奥立泰医药科技有限公司 相关的临床结果
0 项与 西安奥立泰医药科技有限公司 相关的专利（医药）
100 项与 西安奥立泰医药科技有限公司 相关的药物交易
100 项与 西安奥立泰医药科技有限公司 相关的转化医学
