[Translation] A Phase I clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of RS1805 tablets in healthy adult subjects after single and multiple doses, and to evaluate the safety, tolerability and pharmacodynamics of RS1805 tablets in subjects with active ulcerative colitis
主要目的: 通过测量活动性溃疡性结肠炎受试者结肠组织中RS1805的浓度和相关基因表达的变化,评价RS1805的靶向结合;确定RS1805在活动性溃疡性结肠炎受试者中的安全性特征。 探索性目的:研究RS1805对临床结果变化的影响
次要目的:检查RS1805对组织细胞因子、血浆细胞因子水平变化的影响;检查RS1805对炎症生物标志物的影响
[Translation] Primary objective: To evaluate the targeted binding of RS1805 by measuring the concentration of RS1805 and changes in related gene expression in colonic tissue of subjects with active ulcerative colitis; to determine the safety profile of RS1805 in subjects with active ulcerative colitis. Exploratory objective: To study the effect of RS1805 on changes in clinical outcomes
Secondary objective: To examine the effect of RS1805 on changes in tissue cytokine and plasma cytokine levels; to examine the effect of RS1805 on inflammatory biomarkers