Randomized, double-blind, placebo-controlled, Phase IIa dose finding study of single dose GHB11L1 in healthy adults
- Conditions
- GHB-CS07 is a healthy volunteer trial. The intended indication for the investigational medicinal product (GHB11L1) is prevention of influenza A (H1N1).MedDRA version: 12.0Level: LLTClassification code 10022002Term: Influenza A virus infection
- Registration Number
- EUCTR2009-015902-20-AT
- Lead Sponsor
- AVIR Green Hills Biotechnology Research Development Trade AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
•Healthy male volunteers, 18-50 years
•Seronegative for H1N1 (Influenza A/Brisbane/59/07) antibody titres <1:10 detected in hemagglutination inhibition assay)
•Written informed consent to participate in this study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To assess<br>-Safety and tolerability<br>-Pharmacokinetics (shedding)<br>;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.
- Secondary Outcome Measures
Name Time Method