[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of JX2201 in Chinese healthy participants and participants with high Lp(a)
主要目的:
评价参与者单次和多次口服JX2201的安全性和耐受性。
次要目的:
评价参与者单次和多次口服JX2201的药代动力学特征;
评价参与者单次和多次口服JX2201后药效动力学特征;
评价高脂饮食对健康参与者口服JX2201后药代动力学特征的影响;
初步探索JX2201在健康参与者体内的代谢方式及排泄途径;
评价参与者口服JX2201对QT/QTc间期的影响。
[Translation] Primary purpose:
To evaluate the safety and tolerability of single and multiple oral administration of JX2201 in participants.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of single and multiple oral administration of JX2201 in participants;
To evaluate the pharmacodynamic characteristics of single and multiple oral administration of JX2201 in participants;
To evaluate the effect of high-fat diet on the pharmacokinetic characteristics of oral administration of JX2201 in healthy participants;
To preliminarily explore the metabolism and excretion pathway of JX2201 in healthy participants;
To evaluate the effect of oral administration of JX2201 on the QT/QTc interval in participants.