[Translation] A randomized, double-blind, placebo-controlled phase II study to evaluate the safety and efficacy of intravenous infusion of TJ301 (FE 999301) in subjects with active ulcerative colitis
主要目的 评价TJ301在活动性溃疡性结肠炎(UC)患者中的安全性和有效性 次要目的 研究TJ301在活动性溃疡性结肠炎患者中的药代动力学 研究TJ301在活动性溃疡性结肠炎患者中的药效学 研究TJ301在活动性溃疡性结肠炎患者中的免疫原性 探索性目的 探索TJ301在活动性溃疡性结肠炎患者中的药代动力学和药效学关系
[Translation] Primary Objective To evaluate the safety and efficacy of TJ301 in patients with active ulcerative colitis (UC) Secondary Objective To study the pharmacokinetics of TJ301 in patients with active UC To study the pharmacodynamics of TJ301 in patients with active UC To study the immunogenicity of TJ301 in patients with active UC Exploratory Objective To explore the pharmacokinetic and pharmacodynamic relationship of TJ301 in patients with active UC