[Translation] A randomized, double-blind, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of GRK-008 tablets in healthy subjects with single and multiple dose escalation
主要目的:考察健康受试者单次、多次口服GRK-008片的安全性和耐受性。
次要目的:评价GRK-008片在健康成年受试者中单次、多次给药的药代动力学(Pharmacokinetic,PK)特征,及安全性和PK暴露相关性,为后续临床研究提供剂量选择依据。
探索性目的:探索GRK-008对经校正的QT间期和其它ECG参数(心率、PR间期、RR间期和QRS持续时间)的影响;探索GRK-008在人体血浆的代谢物谱。
[Translation] Primary objective: To investigate the safety and tolerability of single and multiple oral administration of GRK-008 tablets in healthy subjects.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of single and multiple administration of GRK-008 tablets in healthy adult subjects, as well as the correlation between safety and PK exposure, and to provide a basis for dose selection for subsequent clinical studies.
Exploratory objective: To explore the effects of GRK-008 on the corrected QT interval and other ECG parameters (heart rate, PR interval, RR interval, and QRS duration); to explore the metabolite profile of GRK-008 in human plasma.