NCT00641225已完成1 期
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis
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
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
- •Must meet criteria for rheumatoid arthritis with functional class I to III.
- •Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age
排除标准
- •Any significant health problems other than rheumatoid arthritis.
- •Treatment of greater than 10 mg of prednisone per day.
- •Treatment with cyclophosphamide.
研究组 & 干预措施
1
Experimental
SBI-087
干预措施: SBI-087 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
时间窗: 12 months
次要结局
- To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis.(12 months)
研究者
研究点 (1)
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