[Translation] A randomized, double-blind, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single and multiple dose escalation of GRK-006 for injection in healthy subjects
主要目的:评价注射用GRK-006在健康成年受试者中单次、多次给药的安全性和耐受性;
次要目的:评价注射用GRK-006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:探索注射用GRK-006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-006在人体血浆的代谢物谱。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple administrations of GRK-006 for injection in healthy adult subjects;
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of single and multiple administrations of GRK-006 for injection 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-006 for injection on the corrected QT interval and other ECG parameters (heart rate, PR interval, RR interval and QRS duration);
Explore the metabolite profile of GRK-006 in human plasma.