NCT01093911已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
研究概览
简要总结
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers and subjects with SLE
排除标准
- •Severe neuropsychiatric or severe renal SLE
- •History of chronic, recurrent, or recent severe infection
- •Significant hematologic abnormalities
- •History of cancer, heart failure, renal disease, liver disease or other serious illness
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
CDP7657
Experimental
CDP7657 in dose escalating cohorts
干预措施: CDP7657 (Biological)
结局指标
主要结局
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
时间窗: Day 0 to 119
次要结局
- Maximum plasma concentration (Cmax)(Day 0 to 119)
- Time corresponding to Cmax (Tmax)(Day 0 to 119)
- Terminal elimination half-life (t 1/2)(Day 0 to 119)
- Plasma levels of anti-CDP7657 antibodies(Day 0 to 119)
研究者
研究点 (8)
Loading locations...
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