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
- 1
- 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
研究组 & 干预措施
GHB04L1
Single dose, dose escalation
干预措施: GHB04L1 (Biological)
SPGN buffer
干预措施: Placebo (Other)
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)