[Translation] A randomized, blinded, dose-escalation, multiple-dose Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of NVS451 fusion protein for injection in Chinese patients with moderate to severe plaque psoriasis
主要目的:评估注射用NVS451融合蛋白多次给药在中重度斑块状银屑病患者中的安全性和耐受性,确定MTD。次要目的:评估注射用NVS451融合蛋白多次给药在中重度斑块状银屑病患者中的人体药代动力学(PK)特征;评估注射用NVS451融合蛋白多次给药在中重度斑块状银屑病患者中的人体药效动力学(PD)特征;评估注射用NVS451融合蛋白多次给药在中重度斑块状银屑病患者中的免疫原性。探索性目的:评估注射用NVS451融合蛋白多次给药在中重度斑块状银屑病患者中的初步临床疗效。
[Translation] Primary objective: To evaluate the safety and tolerability of multiple-dose NVS451 fusion protein for injection in patients with moderate to severe plaque psoriasis and determine the MTD. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of multiple-dose NVS451 fusion protein for injection in patients with moderate to severe plaque psoriasis; To evaluate the pharmacodynamic (PD) characteristics of multiple-dose NVS451 fusion protein for injection in patients with moderate to severe plaque psoriasis; To evaluate the immunogenicity of multiple-dose NVS451 fusion protein for injection in patients with moderate to severe plaque psoriasis. Exploratory objective: To evaluate the preliminary clinical efficacy of multiple-dose NVS451 fusion protein for injection in patients with moderate to severe plaque psoriasis.