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Clinical Trials associated with Recombinant human VEGF receptor-Fc fragment fusion protein(Tiantai Yinkang Biological Medicine Co Ltd)一项开放式、单次给药剂量递增和剂量扩展的重组人VEGF受体-Fc融合蛋白注射液(IBI304)在静脉阻塞性黄斑水肿患者中的I期临床研究
[Translation] An open-label, single-dose, dose-escalation and dose-expansion phase I clinical study of recombinant human VEGF receptor-Fc fusion protein injection (IBI304) in patients with venous occlusive macular edema
主要目的:
评价IBI304静脉阻塞性黄斑水肿受试者中单次给药的安全性和耐受性,确定最大耐受剂量(MTD)及剂量限制性毒性(DLT),为II期临床研究剂量选择提供指导。
次要目的:
初步评价静脉阻塞性黄斑水肿受试者接受IBI304治疗的疗效;
确定IBI304静脉阻塞性黄斑水肿受试者中单次和多次用药后的药代动力学特征。
[Translation] Primary purpose:
To evaluate the safety and tolerability of a single dose of IBI304 in subjects with venous occlusive macular edema, determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), and provide guidance for dose selection in Phase II clinical studies.
Secondary purpose:
To preliminarily evaluate the efficacy of IBI304 in subjects with venous occlusive macular edema;
To determine the pharmacokinetic characteristics of IBI304 after single and multiple doses in subjects with venous occlusive macular edema.
100 Clinical Results associated with Recombinant human VEGF receptor-Fc fragment fusion protein(Tiantai Yinkang Biological Medicine Co Ltd)
100 Translational Medicine associated with Recombinant human VEGF receptor-Fc fragment fusion protein(Tiantai Yinkang Biological Medicine Co Ltd)
100 Patents (Medical) associated with Recombinant human VEGF receptor-Fc fragment fusion protein(Tiantai Yinkang Biological Medicine Co Ltd)
100 Deals associated with Recombinant human VEGF receptor-Fc fragment fusion protein(Tiantai Yinkang Biological Medicine Co Ltd)