NCT01510951已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Moderate to Severe Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 811
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical effects of AMG 811 following single subcutaneous dose administration in subjects with moderate to severe psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 55 years old inclusive at Screening
- •Active but clinically stable, plaque psoriasis
- •Psoriasis involving ≥ 10% of the body surface area
- •A minimum PASI score of ≥ 10 obtained during the screening period
- •Additional inclusion criteria apply
排除标准
- •Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- •Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
- •Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
- •Additional exclusion criteria apply
研究组 & 干预措施
PLACEBO
Placebo Comparator
干预措施: AMG 811 or Placebo (Drug)
AMG 811
Experimental
干预措施: AMG 811 or Placebo (Drug)
结局指标
主要结局
Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 811
时间窗: 16 weeks
次要结局
- Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90(16 weeks)
- Measure the area under the serum concentration curve versus time of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis(16 weeks)
- Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis(16 weeks)
研究者
研究点 (1)
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