[Translation] A randomized, double-blind, placebo-controlled, single/multiple dose escalation and food-effect Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of JK1033 tablets in healthy Chinese adult subjects
主要目的:评价中国健康成年受试者单次和多次口服JK1033片后的安全性和耐受性。次要目的:评价中国健康成年受试者单次和多次口服JK1033片后的PK特征。探索性目的:初步探索JK1033片对按心率校正的QT间期(QTc)的影响;评价食物对口服JK1033片后的PK特征的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of JK1033 tablets after single and multiple oral administration in healthy Chinese adult subjects. Secondary objective: To evaluate the PK characteristics of JK1033 tablets after single and multiple oral administration in healthy Chinese adult subjects. Exploratory objective: To preliminarily explore the effect of JK1033 tablets on the QT interval corrected for heart rate (QTc); to evaluate the effect of food on the PK characteristics of JK1033 tablets after oral administration.