NCT00353756Unknown1 期
A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn's Disease
Avidia2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Safety evaluations
研究概览
简要总结
The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.
详细描述
Determination of safety is the most important goal of this first study with C326. Other goals of the study are to examine:
- pharmacokinetics (change in serum concentrations over time),
- biological activity (change in blood markers relecting activity of Crohn's Disease),
- effects on symptoms of Crohn's disease.
Participants may receive either a single or several intravenous infusions of C326 or matching placebo.
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
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
- •Adults 18 - 65
- •Stable, moderately active Crohn's Disease
- •Otherwise in generally good health
排除标准
- •Variety of concurrent medical conditions
- •Various concomitant medications
结局指标
主要结局
Safety evaluations
次要结局
- Pharmacokinetics
- Biomarker changes -- IL-6, CRP and other acute phase reactants
- Crohn's Disease Activity Index (CDAI)
研究者
研究点 (2)
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