A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.
详细描述
The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis (UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004 serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.
排除标准
- •Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
- •Patients receiving biologic agents and experimental agents are excluded.
研究组 & 干预措施
GB004
GB004 for oral administration daily
干预措施: GB004 (Drug)
Placebo
Placebo for oral administration daily
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: 56 Days
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.
次要结局
- Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004(Day 1 to Day 28)
- Pharmacokinetics: Maximum Concentration (Cmax) of GB004(Day 1 to Day 28)
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004(Day 1 to Day 28)