[Translation] A Phase I randomized, double-blind, placebo/active drug-controlled, dose-escalating, single-dose safety, tolerability, and pharmacokinetics/pharmacodynamics study of HY-022619 for injection in healthy Chinese adult subjects
1、主要目的:评价健康受试者单次注射不同剂量注射用HY-022619的安全性和耐受性。
2、次要目的
1)评价健康受试者单次注射不同剂量注射用HY-022619的药代动力学(PK)特征;
2)评价健康受试者单次注射不同剂量注射用HY-022619的药效学(PD)特征;
3)评价健康受试者单次静脉注射HY-022619与单次口服替格瑞洛片后药代动力学/药效学特征的差异。
探索性目的:评价健康受试者单次给予不同剂量注射用HY-022619后的PK/PD相关性。
[Translation] 1. Primary objective: To evaluate the safety and tolerability of a single injection of different doses of HY-022619 for injection in healthy subjects.
2. Secondary objectives
1) To evaluate the pharmacokinetic (PK) characteristics of a single injection of different doses of HY-022619 for injection in healthy subjects;
2) To evaluate the pharmacodynamic (PD) characteristics of a single injection of different doses of HY-022619 for injection in healthy subjects;
3) To evaluate the differences in pharmacokinetic/pharmacodynamic characteristics after a single intravenous injection of HY-022619 and a single oral administration of ticagrelor tablets in healthy subjects.
Exploratory objective: To evaluate the PK/PD correlation after a single administration of different doses of HY-022619 for injection in healthy subjects.