[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Kylo-11 in Chinese healthy adult subjects after single-dose escalation
主要研究目的:
评估中国健康成年受试者接受Kylo-11单次给药后24周内的安全性、耐受性。 次要研究目的: 评估中国健康成年受试者接受Kylo-11单次给药后整个研究期间的安全性、耐受性。
评估中国健康成年受试者接受Kylo-11单次给药后的药代动力学(PK)特征。
评估中国健康成年受试者接受Kylo-11单次给药后的药效动力学(PD)特征。
评估中国健康成年受试者接受Kylo-11单次给药后的免疫原性特征。
探索性目的:
初步探索Kylo-11单次给药后对脂蛋白(a)[Lp(a)]外其他血脂指标的影响。
初步鉴定Kylo-11单次给药后的代谢产物。
[Translation] Primary study objectives:
To evaluate the safety and tolerability of Kylo-11 in healthy Chinese adult subjects within 24 weeks after a single dose. Secondary study objectives: To evaluate the safety and tolerability of Kylo-11 in healthy Chinese adult subjects throughout the study period after a single dose.
To evaluate the pharmacokinetic (PK) characteristics of Kylo-11 in healthy Chinese adult subjects after a single dose.
To evaluate the pharmacodynamic (PD) characteristics of Kylo-11 in healthy Chinese adult subjects after a single dose.
To evaluate the immunogenicity characteristics of Kylo-11 in healthy Chinese adult subjects after a single dose.
Exploratory objectives:
To preliminarily explore the effects of a single dose of Kylo-11 on other lipid indicators besides lipoprotein (a) [Lp(a)].
To preliminarily identify the metabolites of Kylo-11 after a single dose.