NCT01488201已完成1 期
A Randomized, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KHK4827 in Healthy Volunteers and 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
- 入组人数
- 48
- 主要终点
- Safety
研究概览
简要总结
This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.
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
- Single
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health volunteers
- •Able to provide written informed consent
- •Healthy male between 20 to 45 years of age, inclusive at the time of screening
- •Additional inclusion criteria apply
- •Psoriasis subjects
- •20 to 70 years of age, inclusive at the time of 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
- 未提供
研究组 & 干预措施
KHK4827
Experimental
干预措施: KHK4827 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety
* Adverse events * Clinical laboratory test data * Vital signs
次要结局
- Plasma KHK4827 concentrations and pharmacokinetic parameters(16 time points up to 64 days)
研究者
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