Influenza
Conditions
Keywords
Influenza, monoclonal antibody
Brief summary
The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy adult volunteers that have been inoculated with the influenza A virus
Interventions
BIOLOGICALTCN-032
BIOLOGICALPlacebo (saline)
Sponsors
Theraclone Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 45 years, inclusive. * 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
* Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of clinical signs and symptoms of influenza (including upper respiratory, lower respiratory, systemic and fever). | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of seroconversion to viral challenge strain | up to 28 days after viral challenge |
| The main secondary objective is to evaluate the effect of TCN-032 compared to placebo in total virus shedding (measured by area under the curve [AUC]) from the nasal mucosa, measured by viral culture. | 7 days |
| Pharmacokinetics (PK) and immunogenicity of TCN-032 | up to 28 days after viral challenge |
| Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28. | 28 days after viral challenge |
| Development of viral resistance to TCN-032 | up to 9 days after viral challenge |
| To evaluate the safety of subjects who undergo influenza A viral challenge, with or without treatment with TCN-032. | up to 28 days after viral challenge |
| The duration of influenza symptoms or pyrexia | up to 10 days |
| The time to peak of influenza symptoms or pyrexia | up to 10 days |
| The daily incidence of influenza symptoms or pyrexia. | up to 10 days |
| The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The daily incidence of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The duration of any grade influenza symptoms, or pyrexia | 7 days |
| The time to peak of any grade influenza symptoms, or pyrexia | 7 days |
| The daily incidence of any grade influenza symptoms, or pyrexia | 7 days |
| The peak value of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The time to peak of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The duration of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The daily incidence of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The AUC of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The peak value of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The time to peak of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The duration of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| Incidence of seroprotection to viral challenge strain | up to 28 days after viral challenge |
| Total tissue count and total mucus weight after viral inoculation | 7 days |
| The proportion of any grade influenza symptoms, or pyrexia | 7 days |
Countries
United Kingdom
Contacts
Primary ContactJennifer L. Mitcham
Backup ContactTeri D. Koller
Outcome results
None listed