/ Not yet recruitingPhase 1 纳基奥仑赛注射液治疗难治性系统性红斑狼疮相关的免疫性血小板减少症安全性及耐受性的多中心、开放、单臂I期临床试验
[Translation] A multicenter, open-label, single-arm phase I clinical trial to evaluate the safety and tolerability of Nacioren injection in the treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia
主要目的
评价纳基奥仑赛注射液治疗成人难治性系统性红斑狼疮相关的免疫性血小板减少症的安全性和耐受性。
确定纳基奥仑赛在成人难治性系统性红斑狼疮相关的免疫性血小板减少症受试者中的Ⅱ期推荐剂量(RP2D)。
次要目的:
评价纳基奥仑赛注射液治疗难治性系统性红斑狼疮相关的免疫性血小板减少症的有效性。
评价纳基奥仑赛注射液治疗难治性系统性红斑狼疮相关的免疫性血小板减少症的药代动力学(PK)特征、药效学(PD)特征和免疫原性。
[Translation] Primary Objective
To evaluate the safety and tolerability of Nacioren injection in the treatment of refractory immune thrombocytopenia associated with systemic lupus erythematosus in adults.
To determine the recommended Phase II dose (RP2D) of Nacioren injection in adult subjects with refractory immune thrombocytopenia associated with systemic lupus erythematosus.
Secondary Objectives:
To evaluate the efficacy of Nacioren injection in the treatment of refractory immune thrombocytopenia associated with systemic lupus erythematosus.
To evaluate the pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity of Nacioren injection in the treatment of refractory immune thrombocytopenia associated with systemic lupus erythematosus.
100 Clinical Results associated with Guang Dong He Yuan Sheng Wu Yi Yao You Xian Gong Si
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