[Translation] A randomized, double-blind, placebo-controlled Phase I clinical trial was conducted to evaluate TQA3729 in healthy adult subjects and patients with chronic hepatitis B.
第一部分健康人试验主要目的:评价TQA3729在健康受试者中多剂量、单次、多次给药的安全性和耐受性。次要目的:1、评价TQA3729在健康受试者中多剂量、单次、多次给药的药代动力学;2、评价TQA3729药物代谢转化研究;3、评价食物对TQA3729药代动力学的影响。第二部分乙肝患者试验主要目的:1、评价TQA3729联合口服核苷(酸)类药物在初治的慢乙肝患者中的安全性和耐受性。次要目的:1、评价TQA3729联合口服核苷(酸)类药物在初治的慢乙肝患者中的疗效;2、评价TQA3729联合口服核苷(酸)类药物在初治的慢乙肝患者中的药代动力学特征;
[Translation] Part I. The main purpose of the healthy subjects trial: To evaluate the safety and tolerability of multiple doses, single and multiple administrations of TQA3729 in healthy subjects. Secondary objectives: 1. To evaluate the pharmacokinetics of multiple doses, single and multiple administrations of TQA3729 in healthy subjects; 2. To evaluate the drug metabolism and transformation study of TQA3729; 3. To evaluate the effect of food on the pharmacokinetics of TQA3729. Part II. The main purpose of the hepatitis B patient trial: 1. To evaluate the safety and tolerability of TQA3729 combined with oral nucleoside (acid) drugs in patients with chronic hepatitis B who are undergoing initial treatment. Secondary objectives: 1. To evaluate the efficacy of TQA3729 combined with oral nucleoside (acid) drugs in patients with chronic hepatitis B who are undergoing initial treatment; 2. To evaluate the pharmacokinetic characteristics of TQA3729 combined with oral nucleoside (acid) drugs in patients with chronic hepatitis B who are undergoing initial treatment;