NCT02391259已完成1 期
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
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
- 57
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of SLE with positive ANA
- •Stable disease with no change in SLE therapy within the previous 30 days
- •BMI from 18 to 38 kg/m2
排除标准
- •Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
- •Evidence of renal disease or liver disease
- •Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
- •Prior administration of any other biologic that primarily targets the immune system
研究组 & 干预措施
AMG 557
Experimental
AMG 557 administered as subcutaneous and intravenous doses.
干预措施: AMG 557 (Drug)
Placebo
Placebo Comparator
No active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: From 29 days to 169 days
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
次要结局
- Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax(From 29 days to 169 days)
研究者
研究点 (1)
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