NCT01802697已完成1 期
A Phase i Single Center Study to Evalute the Safety, Tolerability and Pharmacokinetics of Intravenous IdeS After Administration of Single Ascending Doses in Healthy Male Subjects
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
- 29
- 试验地点
- 1
- 主要终点
- Safety as measured by adverse events
研究概览
简要总结
This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).
详细描述
A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and sign informed consent
- •BMI 19-30
排除标准
- •Clinically significant disease
- •Positive HIV, hepatistis B or C
- •Drug abuse
- •Use of medication except paracetamol
研究组 & 干预措施
IdeS
Experimental
Intravenous infusion
干预措施: IdeS (Drug)
PBS Buffer
Placebo Comparator
Intravenous infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as measured by adverse events
时间窗: 64 days
次要结局
- Peak plasma concentration of IdeS(7 days)
研究者
研究点 (1)
Loading locations...
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