NCT00960362已完成1 期
A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus
Argos Therapeutics0 个研究点目标入组 13 人开始时间: 2009年7月最近更新:
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
- 入组人数
- 13
- 主要终点
- Frequency of adverse events
研究概览
简要总结
This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SLE
- •Disease duration longer or equal to 6 months
- •Stable, mild to moderate active SLE
- •Receiving stable maintenance therapy
排除标准
- •Significant lupus nephritis
- •Active central nervous system (CNS) disease
- •Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
- •Active vasculitis requiring treatment
- •Body weight over 120 kg
- •History of cancer
- •Infections
- •viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
- •tuberculosis (TB)
- •Severe systemic microbial infections within the past 12 months prior to dosing
- •Immunosuppressive and immune modulating therapy
研究组 & 干预措施
A
Placebo Comparator
干预措施: placebo (Drug)
B
Experimental
Intravenous cohort 1; 0.01 mg/kg
干预措施: AGS-009 (Drug)
C
Experimental
Intravenous cohort 2; 0.1 mg/kg
干预措施: AGS-009 (Drug)
D
Experimental
Intravenous cohort 3; 0.6 mg/kg
干预措施: AGS-009 (Drug)
E
Experimental
Intravenous cohort 4; 3.0 mg/kg
干预措施: AGS-009 (Drug)
F
Experimental
Intravenous cohort 5; 10 mg/kg
干预措施: AGS-009 (Drug)
G
Experimental
Intravenous cohort 6; 30 mg/kg
干预措施: AGS-009 (Drug)
结局指标
主要结局
Frequency of adverse events
时间窗: From dosing at visit 2 until end of safety visits at visit 8.
次要结局
- Pharmacokinetic - AUC (area under the curve)(From dosing at visit 2 until end of safety visits at visit 8.)
研究者
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