An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Enterome
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Cmax
研究概览
简要总结
Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.
详细描述
This open-label, multicenter study will enroll 8 evaluable patients with active Crohn's disease and will consist of 2 parts. Part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. Part 2 will include the 6 remaining patients with multiple dosing only. This Phase 1b study will investigate the PK, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of EB8018 following 13 days of consecutive BID oral dosing in patients with Crohn's disease.
Part 1 of this study will demonstrate a single oral dose of EB8018 that is safe and tolerable in patients with Crohn's disease and Part 2 of this study will characterize the PK profile when administered as multiple oral doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with active Crohn's disease
EB8018: 3000 mg for the single dose in Part 1 (2 sentinel patients) and 1500 mg BID for multiple dose administration over 13 days in Parts 1 and 2 (2 sentinel patients and 6 remaining patients), oral.
干预措施: EB8018 (First-in-class FimH blocker) (Drug)
结局指标
主要结局
Cmax
时间窗: Day1, Day13
Maximum observed plasma concentration
Tmax
时间窗: Day1
Time to maximum observed plasma concentration
AUC0-24
时间窗: Day1; Day13
Area under the plasma concentration time curve from time 0 to 24 hours
T1/2
时间窗: Day1; Day13
Terminal elimination half-life
次要结局
- QRS complex(Up to Day22)
- RR(Up to Day22)
- PR(Up to Day22)
- HR(Up to Day22)
- AE(Up to Day22)
- QT(Up to Day22)
- BP(Up to Day22)
- Temp(Up to Day22)