[Translation] A multicenter, phase I, double-blind, placebo-controlled clinical trial of VDJ010 for subcutaneous injection in healthy Chinese participants, examining its safety, tolerability, pharmacokinetics, and pharmacodynamics in single-dose and multiple-dose escalation trials in patients with ulcerative colitis.
(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 single-dose and single- or multiple-dose administration in healthy subjects and patients with ulcerative colitis.
(2) To evaluate the pharmacokinetic characteristics of VDJ010 for subcutaneous injection in single-dose and single- or multiple-dose administration in healthy subjects and patients with ulcerative colitis.
(3) To evaluate the immunogenicity of VDJ010 for subcutaneous injection in single-dose and single- or multiple-dose administration in healthy subjects and patients with ulcerative colitis.
(4) To evaluate the pharmacodynamics of VDJ010 for subcutaneous injection in single-dose and single- or multiple-dose administration in healthy subjects and patients with ulcerative colitis.