NCT01867957已完成1 期
A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
- BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
- OBJECTIVE
- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
- STUDY DESIGN
- single-blinded
- randomized
- placebo controlled
- phase 1 study
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
- Single (Participant)
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
- •Healthy male subjects between 18 and 45 years of age at the time of screening visit
- •18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
- •Subjects without congenital or chronic disorder
排除标准
- 未提供
研究组 & 干预措施
High-dose GC1109
Experimental
干预措施: High-dose GC1109 (Biological)
Low-dose Placebo
Placebo Comparator
干预措施: Low-dose Placebo (Biological)
High-dose Placebo
Placebo Comparator
干预措施: High-dose Placebo (Biological)
Low-dose GC1109
Experimental
干预措施: Low-dose GC1109 (Biological)
结局指标
主要结局
Adverse Event
时间窗: 0 - 28 Days
次要结局
- Anti-protective antigen(PA) antibody level (by TNA)(Day 14, Day 28)
- Anti-PA Immunoglobulin G (IgG) (by ELISA)(Day 14, Day 28)
研究者
Myoung-don Oh
Professor, Division of Infectious Diseases, Department of Internal Medicine
Seoul National University Hospital
研究点 (1)
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