Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus.
研究概览
简要总结
It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, 18-50 years
- •Seronegative for H5N1
- •Seronegative for H1N1 (with antibody titers ≤1:20)
- •Written informed consent to participate in this study
排除标准
- •Acute febrile illness
- •Signs of acute or chronic upper or lower tract respiratory illnesses
- •History of severe atopy
- •Seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against H5N1
- •Known increased tendency of nose bleeding
- •Volunteers with clinically relevant abnormal paranasal anatomy
- •Volunteers with clinically relevant abnormal laboratory values
- •Simultaneous treatment with immunosuppressive drugs
- •Clinically relevant history of renal, hepatic, GI, cardiovascular,haematological, skin, endocrine, neurological or immunological diseases
- •History of leukaemia or cancer
- •HIV or Hepatitis B or C seropositivity
- •Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
- •Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
- •Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
- •Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
结局指标
主要结局
To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus.
时间窗: study medication administration until 30 days after end of study
次要结局
- To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally.(day1 until day 29)