[Translation] A randomized, double-blind, placebo-controlled Phase IIa clinical trial to evaluate the efficacy and safety of TQA3810 tablets with or without nucleoside (acid) analogs in treatment-naive or treatment-experienced chronic hepatitis B patients
主要目的:评价 TQA3810 片联合/不联合口服核苷(酸)类药物在初治/经治慢乙肝患者中的安全性和耐受性;
次要目的
评价 TQA3810 片联合/不联合口服核苷(酸)类药物在初治/经治慢乙肝患者中的疗效;
评价 TQA3810 片联合/不联合口服核苷(酸)类药物在初治/经治慢乙肝患者中的药代动力学(PK)特征;
评价 TQA3810 片联合/不联合口服核苷(酸)类药物在初治/经治慢乙肝患者中的药效学(PD)特征;
评价 TQA3810 在初治/经治慢乙肝患者中的血药浓度-QT 间期定量分析(C-QT)研究;
[Translation] Primary objective: To evaluate the safety and tolerability of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment.
Secondary objective
To evaluate the efficacy of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment.
To evaluate the pharmacokinetic (PK) characteristics of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment.
To evaluate the pharmacodynamic (PD) characteristics of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment.
To evaluate the blood drug concentration-QT interval quantitative analysis (C-QT) study of TQA3810 in patients with chronic hepatitis B who have been treated for the first time/after treatment.