[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose escalation clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of recombinant human CTLA-4-Fc fusion protein for injection in healthy subjects
主要目的:
1) 评价注射用重组人CTLA-4-Fc融合蛋白(VDJ002)在中国成年健康受试者中单次给药、静脉滴注、剂量递增的耐受性和安全性。
2) 评价注射用重组人CTLA-4-Fc融合蛋白(VDJ002)在中国成年健康受试者中单次给药、静脉滴注的药代动力学(PK)特征。
次要目的:
1) 评价注射用重组人CTLA-4-Fc融合蛋白(VDJ002)在中国成年健康受试者中单次给药的免疫原性。
2) 初步探索注射用重组人CTLA-4-Fc融合蛋白(VDJ002)在中国成年健康受试者中单次给药的药效动力学(PD)特征。
[Translation] Primary objectives:
1) To evaluate the tolerability and safety of single-dose, intravenous infusion, and dose escalation of recombinant human CTLA-4-Fc fusion protein for injection (VDJ002) in healthy adult Chinese subjects.
2) To evaluate the pharmacokinetic (PK) characteristics of single-dose and intravenous infusion of recombinant human CTLA-4-Fc fusion protein for injection (VDJ002) in healthy adult Chinese subjects.
Secondary objectives:
1) To evaluate the immunogenicity of single-dose recombinant human CTLA-4-Fc fusion protein for injection (VDJ002) in healthy adult Chinese subjects.
2) To preliminarily explore the pharmacodynamic (PD) characteristics of single-dose recombinant human CTLA-4-Fc fusion protein for injection (VDJ002) in healthy adult Chinese subjects.