[Translation] A randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy and safety of SLN12140 in adult patients with primary IgA nephropathy.
主要目的:评价 IgA肾病受试者接受 SLN12140 皮下注射后的初步有效性
次要目的:评价 IgA 肾病受试者接受 SLN12140 皮下注射后的其他有效性指标变化、评价 IgA 肾病受试者接受SLN12140 皮下注射后的安全性、评价 IgA 肾病受试者接受SLN12140 皮下注射后的药代动力学(PK)特征、评价 IgA 肾病受试者接受SLN12140 皮下注射后的药效学(PD)特征、评价 IgA 肾病受试者接受SLN12140 皮下注射后的免疫原性特征。
探索性目的:评价 IgA 肾病受试者接受SLN12140 皮下注射后的长期有效性、评价 IgA 肾病受试者接受SLN12140 皮下注射后的长期安全性、评价 IgA 肾病受试者接受SLN12140 皮下注射后的PD指标长期变化特征、评价 IgA 肾病受试者接受SLN12140 皮下注射后的长期免疫原性特征、在数据允许的情况下,初步建立 SLN12140 的群体药代动力学(Pop-PK)模型,获取群体PK 参数,同时初步探索可能影响个体PK 参数的协变量和暴露-效应(E-R)关系。
[Translation] Primary objective: To evaluate the preliminary efficacy of SLN12140 after subcutaneous injection in subjects with IgA nephropathy.
Secondary objectives: To evaluate changes in other efficacy endpoints after subcutaneous injection of SLN12140 in subjects with IgA nephropathy; to evaluate the safety of SLN12140 after subcutaneous injection in subjects with IgA nephropathy; to evaluate the pharmacokinetic (PK) characteristics of SLN12140 after subcutaneous injection in subjects with IgA nephropathy; to evaluate the immunogenicity characteristics of SLN12140 after subcutaneous injection in subjects with IgA nephropathy.
Exploratory objectives: To evaluate the long-term efficacy, safety, and long-term safety of SLN12140 in IgA nephropathy patients after subcutaneous injection of SLN12140; to evaluate the long-term changes in PD parameters after subcutaneous injection of SLN12140 in IgA nephropathy patients; to evaluate the long-term immunogenicity of SLN12140 after subcutaneous injection of SLN12140 in IgA nephropathy patients; and, where data permits, to preliminarily establish a population pharmacokinetic (Pop-PK) model of SLN12140 to obtain population PK parameters, and to preliminarily explore covariates and exposure-response (E-R) relationships that may affect individual PK parameters.