GHB-CS07 is a healthy volunteer trial. The intended indication for the investigational medicinal product (GHB11L1) is prevention of influenza A (H1N1). MedDRA version: 12.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection
Conditions
Interventions
Product Name: GHB11L1
Product Code: GHB11L1
Pharmaceutical Form: Nasal spray*
Pharmaceutical form of the placebo: Nasal spray*
Route of administration of the placebo: Nasal use
Sponsors
AVIR Green Hills Biotechnology Research Development Trade AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Healthy male volunteers, 18-50 years • Seronegative for H1N1 (Influenza A/Brisbane/59/07) antibody titres =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute febrile illness (>37.0°C) • Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.) • History of severe atopy • Seasonal influenza vaccination from 2007/2008 onwards and/or pandemic influenza vaccination at any time • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess - Safety and tolerability - Pharmacokinetics (shedding) ;Main Objective: To assess the immunogenicity (HAI, MNA, IgA, IgG, Granzyme B ELISPOT) of a single intranasal dose of GHB11L1 ;Primary end point(s): The primary endpoint is to assess the immunogenicity of GHB11L1 administered as single dose liquid nasal spray against influenza A (H1N1) virus. For this purpose 48 healthy volunteers are planned to be included in a phase IIa dose finding study where 16 subjects per each of three dose levels will be randomized in a ratio of 3:1 for verum or placebo in parallel according to a fixed dose finding plan. | — |
Countries
Austria
Outcome results
None listed