[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of single and multiple ascending doses of Kylo-0603 capsules in healthy subjects
主要研究目的:
评估中国健康成年受试者单次和多次口服Kylo-0603胶囊后的安全性、耐受性。
次要研究目的:
评估中国健康成年受试者单次和多次口服Kylo-0603胶囊后的药代动力学(PK)特征和代谢产物的初步鉴定。
初步评估食物对健康受试者单次口服Kylo-0603胶囊后PK特征的影响。 探索性目的:
探索单次和多次给药后Kylo-0603的药效学生物标志物。
[Translation] Primary study objectives:
To evaluate the safety and tolerability of Kylo-0603 capsules after single and multiple oral administration in healthy Chinese adult subjects.
Secondary study objectives:
To evaluate the pharmacokinetic (PK) characteristics and preliminary identification of metabolites of Kylo-0603 capsules after single and multiple oral administration in healthy Chinese adult subjects.
To preliminarily evaluate the effect of food on the PK characteristics of Kylo-0603 capsules after a single oral administration in healthy subjects. Exploratory objectives:
To explore the pharmacodynamic biomarkers of Kylo-0603 after single and multiple administration.