[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SG301 SC injection in healthy subjects after single administration and in subjects with systemic lupus erythematosus after multiple administration
主要目的:评估SG301 SC 注射液在健康受试者中单次给药和在系统性红斑狼疮(SLE)受试者中多次给药的安全性和耐受性。
次要目的:(A 部分-健康受试者)
评估 SG301 SC 注射液在健康受试者中单次给药PK特征和免疫原性特征;
次要目的(B 部分-SLE 受试者)
确定 SG301 SC 注射液在 SLE 受试者中的RP2D;
评估 SG301 SC 注射液在 SLE 受试者中单次/多次给药的 PK 特征、多次给药的免疫原性、多次给药的CD38受体占有率;
初步评估 SG301 SC 注射液在 SLE 受试者中多次给药的生物标志物的变化、疾病活动度的变化;
探索性目的(B 部分-SLE 受试者)
探索SG301 SC 注射液在 SLE 受试者中免疫细胞亚群的变化、免疫球蛋白的变化、BILAG-2004和 PGA 的变化。
[Translation] Primary objective: To evaluate the safety and tolerability of SG301 SC injection after single administration in healthy subjects and multiple administration in subjects with systemic lupus erythematosus (SLE).
Secondary objectives: (Part A - healthy subjects)
Evaluate the single-dose PK characteristics and immunogenicity characteristics of SG301 SC injection in healthy subjects;
Secondary objectives (Part B - SLE subjects)
Determine the RP2D of SG301 SC injection in SLE subjects;
Evaluate the PK characteristics of single/multiple administrations, immunogenicity of multiple administrations, and CD38 receptor occupancy of multiple administrations of SG301 SC injection in SLE subjects;
Preliminary evaluation of changes in biomarkers and changes in disease activity of multiple administrations of SG301 SC injection in SLE subjects;
Exploratory objectives (Part B - SLE subjects)
Explore the changes in immune cell subsets, immunoglobulins, BILAG-2004 and PGA of SG301 SC injection in SLE subjects.