[Translation] Phase I/II clinical study on the safety, efficacy and pharmacokinetics of lepsulotide acetate oral lyophilized powder combined with mesalazine in the treatment of mild ulcerative colitis
主要目的:评估醋酸来普舒肽口服冻干粉治疗活动期轻度溃疡性结肠炎的耐受性和安全性 次要目的:考察LH025在活动期轻度溃疡性结肠炎患者中的药代动力学特征;研究LH025治疗活动期轻度溃疡性结肠炎患者的有效性 探索目的:探索LH025在活动期轻度溃疡性结肠炎患者中的药代动力学指标和药效学指标的关系
[Translation] Primary objective: To evaluate the tolerability and safety of lepsulotide acetate oral lyophilized powder in the treatment of active mild ulcerative colitis Secondary objective: To investigate the pharmacokinetic characteristics of LH025 in patients with active mild ulcerative colitis; To study the effectiveness of LH025 in the treatment of patients with active mild ulcerative colitis Exploratory objective: To explore the relationship between the pharmacokinetic and pharmacodynamic indicators of LH025 in patients with active mild ulcerative colitis