[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of YKYY032 injection in healthy participants with elevated lipoprotein (a) levels.
主要目的
评价Lp(a)升高参与者单次皮下注射YKYY032注射液后的安全性和耐受性;
次要目的 评价Lp(a)升高参与者单次皮下注射YKYY032注射液后的药代动力学(Pharmacokinetics,PK)特征; 评价Lp(a)升高参与者单次皮下注射YKYY032注射液后的药效学(Pharmacodynamics,PD)特征;
探索性目的
评价Lp(a)升高参与者单次皮下注射YKYY032注射液后的免疫原性;
评价单次皮下注射YKYY032注射液后对QTc间期的影响;
评价Lp(a)升高参与者单次皮下注射YKYY032注射液后对其他探索性生物标志物的影响。
[Translation] Primary Objectives:
Evaluate the safety and tolerability of a single subcutaneous injection of YKYY032 in participants with elevated Lp(a).
Secondary Objectives:
Evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of YKYY032 in participants with elevated Lp(a);
Evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of YKYY032 in participants with elevated Lp(a).
Exploratory Objectives:
Evaluate the immunogenicity of a single subcutaneous injection of YKYY032 in participants with elevated Lp(a);
Evaluate the effect of a single subcutaneous injection of YKYY032 on the QTc interval;
Evaluate the effect of a single subcutaneous injection of YKYY032 on other exploratory biomarkers in participants with elevated Lp(a).