Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza
Phase 2
- Conditions
- Influenza
- Interventions
- Biological: Placebo (saline)Biological: TCN-032
- Registration Number
- NCT01719874
- Lead Sponsor
- Theraclone Sciences, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (saline) Placebo (saline) single-dose, administered intravenously TCN-032 TCN-032 single-dose, administered intravenously
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 proportion of any grade influenza symptoms, or pyrexia 7 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 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 The daily incidence of virus shedding from the nasal mucosa measured by qPCR 6 days Incidence of seroconversion to viral challenge strain up to 28 days after viral challenge 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