NCT00815906已完成1 期
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese 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
- 20
- 试验地点
- 1
- 主要终点
- Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
- •Rheumatoid arthritis disease onset at >16 years of age and duration of disease at least 6 months.
- •Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.
排除标准
- •Any significant health problems other than rheumatoid arthritis.
- •Treatment of greater than 10 mg of prednisone per day.
- •Therapy with immunosuppressants within 6 months before study day 1
研究组 & 干预措施
SBI-087 0.15 mg IV
Experimental
干预措施: SBI-087 (Drug)
SBI-087 0.5 mg IV
Experimental
干预措施: SBI-087 (Drug)
SBI-087 100 mg SC
Experimental
干预措施: SBI-087 (Drug)
SBI-087 200 mg SC
Experimental
干预措施: SBI-087 (Drug)
结局指标
主要结局
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
时间窗: 12 months
次要结局
- To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087(12 month)
- To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA(12 months)
- To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087(12 month)
研究者
研究点 (1)
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