[Translation] This is a dose-escalation, open-label, multicenter Phase I clinical trial evaluating the safety, tolerability, preliminary efficacy, pharmacodynamics, and pharmacokinetics of EA5 injection in adult participants with antiphospholipid syndrome (APS) and recurrent thrombosis under the established criteria of treatment.
主要目的: 评价在标准治疗背景下,EA5 注射液治疗APS 伴复发性血栓成年试验参与者的安全性和耐受性。
次要目的:评价EA5 注射液治疗APS 伴复发性血栓成年试验参与者的初步疗效。评估EA5 注射液的免疫原性。评估EA5 注射液的药代动力学特征。评估EA5 注射液对末端补体活性的抑制作用。探讨EA5 注射液治疗APS 的生物标志物变化(如D-二聚体、凝血酶-抗
凝血酶复合物(TAT))。
探索性目的:进一步评估EA5 注射液对APS 的生物标志物影响【超敏C 反应蛋白(hs-CRP)、血管细胞粘附分子(VCAM-1)】。
[Translation] Primary Objective: To evaluate the safety and tolerability of EA5 injection in adult participants with APS and recurrent thrombosis under standard treatment.
Secondary Objectives: To evaluate the preliminary efficacy of EA5 injection in adult participants with APS and recurrent thrombosis. To assess the immunogenicity of EA5 injection. To assess the pharmacokinetic characteristics of EA5 injection. To assess the inhibitory effect of EA5 injection on terminal complement activity. To investigate changes in biomarkers (e.g., D-dimer, thrombin-antithrombin complex (TAT)) in APS treatment.
Exploratory Objectives: To further evaluate the effects of EA5 injection on biomarkers of APS [high-sensitivity C-reactive protein (hs-CRP), vascular cell adhesion molecule (VCAM-1)].