[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of KYS202002A injection in patients with systemic lupus erythematosus with single and multiple doses
主要研究目的:评价KYS202002A注射液静脉输注单次给药和多次给药治疗系统性红斑狼疮的安全性和耐受性。
次要研究目的:初步评价KYS202002A注射液静脉输注单次和多次给药治疗系统性红斑狼疮的疗效;评价KYS202002A注射液静脉输注单次和多次给药后药代动力学(PK)/药效动力学(PD)特征及免疫原性。
[Translation] The main purpose of the study is to evaluate the safety and tolerability of single and multiple intravenous infusions of KYS202002A injection in the treatment of systemic lupus erythematosus.
The secondary purpose of the study is to preliminarily evaluate the efficacy of single and multiple intravenous infusions of KYS202002A injection in the treatment of systemic lupus erythematosus; to evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics and immunogenicity of single and multiple intravenous infusions of KYS202002A injection.