Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza

Theraclone Sciences

Status and phase: Unknown; Phase 2

Conditions: Influenza

Treatments: Biological: TCN-032; Biological: Placebo (saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01719874

TCN-032-002

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

TCN-032

Experimental group

Description:

single-dose, administered intravenously

Treatment:

Biological: TCN-032

Placebo (saline)

Placebo Comparator group

Description:

single-dose, administered intravenously

Treatment:

Biological: Placebo (saline)