[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SYH2053 injection in Chinese participants with normal or elevated low-density lipoprotein cholesterol
主要目的:评价SYH2053注射液在中国不同LDL-C血清浓度水平参与者中单次皮下注射给药的安全性和耐受性;
次要目的:评价SYH2053注射液在中国不同LDL-C血清浓度水平参与者中单次皮下注射给药的PK、PD特征以及对QT/QTc间期的影响
探索性目的:评价SYH2053注射液在中国不同LDL-C血清浓度水平参与者中单次皮下注射给药后探索性生物标志物表达水平的变化特征;评价SYH2053注射液在中国不同LDL-C血清浓度水平参与者中单次皮下注射给药的免疫原性特征
[Translation] Primary objective: To evaluate the safety and tolerability of a single subcutaneous injection of SYH2053 injection in Chinese participants with different LDL-C serum concentration levels;
Secondary objective: To evaluate the PK, PD characteristics and the effect on the QT/QTc interval of a single subcutaneous injection of SYH2053 injection in Chinese participants with different LDL-C serum concentration levels
Exploratory objective: To evaluate the changing characteristics of the expression levels of exploratory biomarkers after a single subcutaneous injection of SYH2053 injection in Chinese participants with different LDL-C serum concentration levels; To evaluate the immunogenicity characteristics of a single subcutaneous injection of SYH2053 injection in Chinese participants with different LDL-C serum concentration levels