NCT04835168撤回1 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
NImmune Biopharma0 个研究点开始时间: 2022年1月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Incidence and severity of AEs
研究概览
简要总结
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
BT-11 low
Experimental
Oral
干预措施: BT-11 low (Drug)
BT-11 high
Experimental
Oral
干预措施: BT-11 high (Drug)
Placebo
Placebo Comparator
Oral
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of AEs
时间窗: 12 Weeks
次要结局
未报告次要终点
研究者
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