NCT01299142Unknown1 期
Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety assessments
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.
详细描述
Primary -
- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo
Secondary
- To evaluate the pharmacokinetics (PK) of a singel intravenous administration of FGI-101-1A6
- To evaluate the immunogenicity of FGI-101-1A6
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers ages 18-45
- •Normal laboratory (blood tests) results
排除标准
- •Prior immunization with live-attenuated vaccines
研究组 & 干预措施
FGI-101-1A6
Experimental
Intervention: Drug-FGI-101-1A6
干预措施: FGI-101-1A6 (Drug)
Placebo
Placebo Comparator
Intervention: Drug-Placebo
干预措施: FGI-101-1A6 (Drug)
结局指标
主要结局
Safety assessments
时间窗: 60 days following infusion
Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 60, or the early withdrawal, if applicable
次要结局
- Pharmacokinetic analysis (PK)(60 days following infusion)
- Immunogenicity(From day 1 up to day 60 following infusion)
研究者
研究点 (1)
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