[Translation] A Phase Ib clinical study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic characteristics and preliminary efficacy of VSA012 injection in the treatment of paroxysmal nocturnal hemoglobinuria subjects who are naive to complement inhibitors or have not recently received complement inhibitor treatment
主要目的:
· 评价 VSA012 在中国阵发性睡眠性血红蛋白尿症受试者中的安全性和耐受性;
· 评价 VSA012 在中国阵发性睡眠性血红蛋白尿症受试者中的初步有效性。
次要目的:
· 评价 VSA012 在中国阵发性睡眠性血红蛋白尿症受试者中的药代动力学(PK)特征;
· 评价 VSA012 在中国阵发性睡眠性血红蛋白尿症受试者中的药效学(PD)特征。
[Translation] Primary objectives:
· To evaluate the safety and tolerability of VSA012 in Chinese subjects with paroxysmal nocturnal hemoglobinuria;
· To evaluate the preliminary efficacy of VSA012 in Chinese subjects with paroxysmal nocturnal hemoglobinuria.
Secondary objectives:
· To evaluate the pharmacokinetic (PK) characteristics of VSA012 in Chinese subjects with paroxysmal nocturnal hemoglobinuria;
· To evaluate the pharmacodynamic (PD) characteristics of VSA012 in Chinese subjects with paroxysmal nocturnal hemoglobinuria.