Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

Inclusion criteria

• 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

Exclusion criteria

• 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