Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers

Exclusion Criteria

• •Acute febrile illness (\>37.3°C)
• •Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
• •History of severe atopy
• •Seasonal influenza vaccination 2005/2006, 2006/2007 and/or 2007/2008 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 incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
• •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