Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza
A Phase 2a, Double-Blind, Placebo-Controlled Study TCN 032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Subjects Challenged With H3N2 Influenza A Virus
1 other identifier
interventional
64
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedNovember 1, 2012
October 1, 2012
4 months
October 25, 2012
October 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (28)
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
- +23 more secondary outcomes
Study Arms (2)
TCN-032
EXPERIMENTALsingle-dose, administered intravenously
Placebo (saline)
PLACEBO COMPARATORsingle-dose, administered intravenously
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
London, United Kingdom
Related Publications (1)
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.
PMID: 25281755DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eleanor L Ramos, MD
Theraclone Sciences, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2012
First Posted
November 1, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
November 1, 2012
Record last verified: 2012-10