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

Inclusion Criteria: * Healthy male volunteers, 18-50 years * Immune status: seronegative with respect to the applied virus antigens with antibody titres \<1:10 detected in the HAI assay with the corresponding antigens) * Written informed consent to participate in this study 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