NCT00626184已完成1 期
A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- safety and tolerability
研究概览
简要总结
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
详细描述
A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Placebo Comparator
Placebo
干预措施: 4 dose levels of ALV003 (Drug)
B
Active Comparator
Active study Drug: ALV003
干预措施: 4 dose levels of ALV003 (Drug)
结局指标
主要结局
safety and tolerability
时间窗: Throughout
次要结局
未报告次要终点
研究者
研究点 (1)
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