[Translation] A single-center, double-blind, randomized, placebo-controlled phase I clinical study of QJ-19-0002 tablets in healthy Chinese subjects to evaluate the tolerability, safety and pharmacokinetics
主要目的:1. 评价健康受试者单次和多次口服QJ-19-0002片后的耐受性与安全性,确定最大耐受剂量,考察该药的不良反应特征;2. 评价健康受试者单次和多次口服QJ-19-0002片后的药代动力学(PK)特征,考察线性特征以及多次给药的蓄积性;3. 通过C-QTc分析评估该药的心脏毒性。次要目的:评价健康受试者单次和多次口服QJ-19-0002片后的药效动力学(PD)特征。
[Translation] Primary objectives: 1. To evaluate the tolerability and safety of QJ-19-0002 tablets after single and multiple oral administration in healthy subjects, determine the maximum tolerated dose, and investigate the adverse reaction characteristics of the drug; 2. To evaluate the pharmacokinetic (PK) characteristics of QJ-19-0002 tablets after single and multiple oral administration in healthy subjects, investigate the linear characteristics and accumulation of multiple administrations; 3. To evaluate the cardiotoxicity of the drug by C-QTc analysis. Secondary objectives: To evaluate the pharmacodynamic (PD) characteristics of QJ-19-0002 tablets after single and multiple oral administration in healthy subjects.