[Translation] A single-center, randomized, double-blind, placebo-controlled, multiple-dose, single-dose, and multiple-dose phase I clinical trial to evaluate the tolerability, pharmacodynamics, and pharmacokinetics of LW231 tablets in healthy subjects and patients with chronic hepatitis B
Part 1 : Ia 期临床试验(健康受试者)
主要目的
评价 LW231 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
评价 LW231 在健康受试者中多剂量、 单次、 多次给药的药代动力学特征;
评价 LW231 药物代谢转化;
评价食物对 LW231 药代动力学的影响;
Part 2 : Ib 期临床试验(健康受试者中药物-药物相互作用研究)
评估 LW231 与恩替卡韦、 富马酸丙酚替诺福韦(TAF) 的药物-药物相互作用, 以及LW231 与恩替卡韦或 TAF 联合用药在健康受试者中的药代动力学特性和耐受性, 为后续临床试验给药方案设计提供依据。
Part 3: Ⅰ c 期临床试验(免疫耐受期慢性乙型肝炎患者)
主要目的
评价 LW231 在免疫耐受期慢性乙型肝炎患者中的安全性和耐受性;
次要目的
评价 LW231 在免疫耐受期慢性乙型肝炎患者中的初步疗效;
评价 LW231 在免疫耐受期慢乙肝患者中的药代动力学特征。
[Translation] Part 1: Phase Ia clinical trial (healthy subjects)
Main purpose
To evaluate the safety and tolerability of LW231 in healthy subjects after multiple, single and multiple administrations;
Secondary purpose
To evaluate the pharmacokinetic characteristics of LW231 in healthy subjects after multiple, single and multiple administrations;
To evaluate the drug metabolism transformation of LW231;
To evaluate the effect of food on the pharmacokinetics of LW231;
Part 2: Phase Ib clinical trial (drug-drug interaction study in healthy subjects)
To evaluate the drug-drug interaction between LW231 and entecavir and tenofovir alafenamide fumarate (TAF), as well as the pharmacokinetic characteristics and tolerability of LW231 combined with entecavir or TAF in healthy subjects, to provide a basis for the design of dosing regimens for subsequent clinical trials.
Part 3: Phase Ⅰc clinical trial (patients with chronic hepatitis B in the immune tolerance phase)
Main purpose
To evaluate the safety and tolerability of LW231 in patients with chronic hepatitis B in the immune tolerance phase;
Secondary purpose
To evaluate the preliminary efficacy of LW231 in patients with chronic hepatitis B in the immune tolerance phase;
To evaluate the pharmacokinetic characteristics of LW231 in patients with chronic hepatitis B in the immune tolerance phase.