[Translation] A randomized, double-blind, placebo-controlled phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of GR1603 injection in patients with moderate to severe systemic lupus erythematosus after multiple intravenous administration
主要目的:评价GR1603注射液在中、重度系统性红斑狼疮患者中多次给药的耐受性和安全性特征。
次要目的:评价GR1603注射液在中、重度系统性红斑狼疮患者体内多次给药的药代动力学特征以及初步疗效、免疫原性。
探索目的:探索GR1603注射液在中、重度系统性红斑狼疮患者体内多次给药前后外周血中Ⅰ型IFN基因转录水平的变化。
[Translation] Primary objective: To evaluate the tolerability and safety characteristics of GR1603 injection after multiple administration in patients with moderate to severe systemic lupus erythematosus.
Secondary objective: To evaluate the pharmacokinetic characteristics, preliminary efficacy and immunogenicity of GR1603 injection after multiple administration in patients with moderate to severe systemic lupus erythematosus.
Exploratory objective: To explore the changes in the transcription level of type I IFN gene in peripheral blood before and after multiple administration of GR1603 injection in patients with moderate to severe systemic lupus erythematosus.