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

Phase 2UnknownNCT01719874

Theraclone Sciences, Inc.64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Influenza

Interventions

TCN-032BIOLOGICAL

Placebo (saline)BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 7 days

Secondary Outcomes

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.

Time frame: 7 days

Pharmacokinetics (PK) and immunogenicity of TCN-032

Time frame: up to 28 days after viral challenge

Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28.

Time frame: 28 days after viral challenge

Development of viral resistance to TCN-032

Time frame: 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.

Time frame: up to 28 days after viral challenge

The duration of influenza symptoms or pyrexia

Time frame: up to 10 days

The time to peak of influenza symptoms or pyrexia

Time frame: up to 10 days

The daily incidence of influenza symptoms or pyrexia.

Time frame: up to 10 days

The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.

Central Contacts

Jennifer L. Mitcham

CONTACT

206-805-1608 jmitcham@theraclone-sciences.com

Teri D. Koller

CONTACT

206-805-1635 tkoller@theraclone-sciences.com

Data from ClinicalTrials.gov

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