[Translation] A multicenter, phase I, double-blind, placebo-controlled clinical trial of the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose escalation of VDJ010 for subcutaneous injection in Chinese healthy subjects.
(1)评价皮下注射用VDJ010在健康受试者单次及溃疡性结肠炎患者中单次及多次给药的安全性和耐受性。
(2)评价皮下注射用VDJ010在健康受试者单次及溃疡性结肠炎患者中单次及多次给药的药代动力学特征。
(3)评价皮下注射用VDJ010在健康受试者单次及溃疡性结肠炎患者中单次及多次给药的免疫原性。
(4)评价皮下注射用VDJ010在健康受试者单次及溃疡性结肠炎患者中单次及多次给药的药效动力学。
[Translation] (1) To evaluate the safety and tolerability of VDJ010 for subcutaneous injection in healthy subjects and in patients with ulcerative colitis after single and multiple administrations.
(2) To evaluate the pharmacokinetic characteristics of VDJ010 for subcutaneous injection in healthy subjects and in patients with ulcerative colitis after single and multiple administrations.
(3) To evaluate the immunogenicity of VDJ010 for subcutaneous injection in healthy subjects and in patients with ulcerative colitis after single and multiple administrations.
(4) To evaluate the pharmacodynamics of VDJ010 for subcutaneous injection in healthy subjects and in patients with ulcerative colitis after single and multiple administrations.