[Translation] A randomized, double-blind, placebo-controlled phase IIa clinical trial was conducted to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection in patients with moderate to severe active ulcerative colitis.
剂量探索阶段:
评估 HX15001 注射液多次给药在中重度活动性 UC 患者中的安全性和耐受性药代动力学特征和初步有效性。
剂量验证阶段:
主要目的 :
评估 在推荐剂量下,HX15001 注射液多次给药在中重度活动性 UC 患者中的初步有效性、安全性和PK特征。
[Translation] Dosage Exploration Phase: To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of multiple doses of HX15001 injection in patients with moderate to severe active UC.
Dosage Validation Phase:
Primary Objective: To evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of multiple doses of HX15001 injection in patients with moderate to severe active UC at the recommended dose.