[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety, preliminary efficacy, and pharmacokinetic/pharmacodynamic characteristics of RG002C0106 injection in subjects with primary IgA nephropathy
主要目的:
1.评估IgA肾病患者皮下注射RG002C0106后对于蛋白尿的改善;
2.评估IgA肾病患者皮下注射RG002C0106后的安全性和耐受性;
次要目的:
1.评估IgA肾病患者皮下注射RG002C0106后的其他临床有效性指标变化;
2.评估IgA肾病患者皮下注射RG002C0106后的药效学特征、药代动力学特征、免疫原性特征。
[Translation] Primary Objectives:
1. Evaluate the improvement of proteinuria after subcutaneous administration of RG002C0106 in patients with IgA nephropathy;
2. Evaluate the safety and tolerability of RG002C0106 after subcutaneous administration in patients with IgA nephropathy;
Secondary Objectives:
1. Evaluate changes in other clinical efficacy indicators after subcutaneous administration of RG002C0106 in patients with IgA nephropathy;
2. Evaluate the pharmacodynamic, pharmacokinetic, and immunogenic properties of RG002C0106 after subcutaneous administration in patients with IgA nephropathy.