Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza
NCT ID: NCT01719874
Last Updated: 2012-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
64 participants
INTERVENTIONAL
2012-08-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TCN-032
single-dose, administered intravenously
TCN-032
Placebo (saline)
single-dose, administered intravenously
Placebo (saline)
Interventions
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TCN-032
Placebo (saline)
Eligibility Criteria
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Inclusion Criteria
* In good health with no history of major medical conditions
* Female subjects must not be pregnant or nursing
* Have not been vaccinated for influenza virus since 2006
* Serosusceptible to the challenge virus
* Non-smoker or current smoker willing/able to desist
Exclusion Criteria
* History or evidence of autoimmune disease
* Any history during adulthood of asthma, history of COPD, pulmonary hypertension, reactive airway disease, any chronic lung condition of any etiology), or any use of a bronchodilator or other asthma medication within adulthood
* History or clinical evidence of recurrent lower respiratory tract infection
* Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) antibody screen
* Subject is diabetic
* History of frequent epistaxis (nose bleeds)
* Any nasal or sinus surgery within 6 months of the screening visit
* Recent and/or recurrent history of autonomic dysfunction (fainting, palpitations, etc.)
* Any laboratory test, ECG or spirometry which is abnormal and which is deemed by the Investigator(s) to be clinically significant.
* Any acute medical condition or significant past medical history of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, haematological, locomotor, immunologic, ophthalmologic, metabolic, endocrine, or other diseases
* Major surgery within 3 months prior to screening visit
* Evidence of drug of abuse or positive urine Class A drug or alcohol screen prior to admission
* Subjects symptomatic with hay fever
* Subjects with a history of significant adverse reactions/allergies
* History of allergy or intolerance to oseltamivir or zanamivir.
* Health care workers (including doctors, nurses, medical students, and allied healthcare professionals) anticipated to have patient contact within 2 weeks of viral challenge.
18 Years
45 Years
ALL
Yes
Sponsors
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Theraclone Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eleanor L Ramos, MD
Role: STUDY_DIRECTOR
Theraclone Sciences, Inc.
Locations
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London, , United Kingdom
Countries
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Central Contacts
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References
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Ramos EL, Mitcham JL, Koller TD, Bonavia A, Usner DW, Balaratnam G, Fredlund P, Swiderek KM. Efficacy and safety of treatment with an anti-m2e monoclonal antibody in experimental human influenza. J Infect Dis. 2015 Apr 1;211(7):1038-44. doi: 10.1093/infdis/jiu539. Epub 2014 Oct 3.
Other Identifiers
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TCN-032-002
Identifier Type: -
Identifier Source: org_study_id