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Clinical Trials associated with YFQLXB-UC01一项评价YFQLXB-UC01注射液静脉输注治疗失代偿期肝硬化的安全性、耐受性及有效性临床试验
[Translation] A clinical trial to evaluate the safety, tolerability and efficacy of intravenous infusion of YFQLXB-UC01 injection in the treatment of decompensated liver cirrhosis
Ⅰ期(单次+多次给药、随机开放、剂量递增)
主要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的安全性和耐受性,确定临床用药的安全剂量。
次要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的初步有效性,为后续临床试验方案设计提供依据。
探索性目的:
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药代动力学特征和免疫原性。
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药效动力学(PD)特征。
Ⅱ期(多次给药、随机双盲、安慰剂对照)
主要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的初步有效性。
次要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的安全性和耐受性。
探索性目的:
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药代动力学特征和免疫原性。
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药效动力学(PD)特征
[Translation] Phase I (single + multiple administration, randomized open, dose escalation)
Main purpose:
To evaluate the safety and tolerability of YFQLXB-UC01 injection in patients with decompensated cirrhosis and determine the safe dose for clinical use.
Secondary purpose:
To evaluate the preliminary efficacy of YFQLXB-UC01 injection in patients with decompensated cirrhosis and provide a basis for the design of subsequent clinical trial programs.
Exploratory purpose:
To explore the pharmacokinetic characteristics and immunogenicity of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
To explore the pharmacodynamic (PD) characteristics of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
Phase II (multiple administration, randomized double-blind, placebo-controlled)
Main purpose:
To evaluate the preliminary efficacy of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
Secondary purpose:
To evaluate the safety and tolerability of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
Exploratory purpose:
To explore the pharmacokinetic characteristics and immunogenicity of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
To explore the pharmacodynamic (PD) characteristics of YFQLXB-UC01 injection in patients with decompensated cirrhosis
100 Clinical Results associated with YFQLXB-UC01
100 Translational Medicine associated with YFQLXB-UC01
100 Patents (Medical) associated with YFQLXB-UC01
100 Deals associated with YFQLXB-UC01