NCT01202695已完成1 期
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers
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
- 50
- 试验地点
- 1
- 主要终点
- Safety assessments
研究概览
简要总结
Primary:
• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo
Secondary:
- To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
- To evaluate the immunogenicity of AVP-21D9
详细描述
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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, between 18 and 45 years of age
- •Normal laboratory (blood test) results
排除标准
- •Prior immunization with anthrax vaccine
研究组 & 干预措施
AVP-21D9
Experimental
干预措施: AVP-21D9 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessments
时间窗: 90 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 90 or the early withdrawl visit, if applicable.
次要结局
- Pharmacokinetics (PK) analysis(90 days following infusion)
- Immunogenicity analysis(From day 1 up to day 90 following infusion)
研究者
研究点 (1)
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