[Translation] Phase I clinical trial to evaluate the tolerability, safety and pharmacokinetic characteristics of single and multiple oral administration of QR056251 capsules in healthy Chinese adult subjects and the effect of food on the pharmacokinetics of QR056251 capsules
主要目的:评估中国健康成年受试者单、多次口服不同剂量 QR056251胶囊后的安全性和耐受性; 次要目的:评估中国健康成年受试者单、多次口服不同剂量QR056251胶囊后的药代动力学(Pharmacokinetics, PK)特征及食物对QR056251胶囊PK特征的影响;
探索性目的:初步开展人体中药物代谢产物的探索性研究,探索QR056251 胶囊的探索性指标相关标志物水平及其与 PK 参数的关系。
[Translation] Primary purpose: To evaluate the safety and tolerability of QR056251 capsules after single and multiple oral administration of different doses in healthy Chinese adult subjects; Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of QR056251 capsules after single and multiple oral administration of different doses in healthy Chinese adult subjects and the effect of food on the PK characteristics of QR056251 capsules;
Exploratory purpose: To conduct preliminary exploratory studies on drug metabolites in humans, and to explore the levels of exploratory index-related markers of QR056251 capsules and their relationship with PK parameters.