Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Combined/Uncombined Nucleoside (Acid) Analogues of TQA3810 Tablets in Primary/Treated Patients With Chronic Hepatitis B
To evaluate the efficacy and safety of combined/uncombined nucleoside (acid) analogues of TQA3810 tablets.
评估 TQA3810 片联合/不联合核苷(酸)类似物在初治/经治慢性乙型肝炎患者中的疗效和安全性的随机、双盲、安慰剂对照的 IIa 期临床试验
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;
A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets
This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.
100 项与 TQA-3810 相关的专利(医药)