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

This study is currently recruiting participants.
Verified October 2012 by Theraclone Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01719874
First received: October 25, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Influenza
 Biological: TCN-032
Biological: Placebo (saline)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Fever Flu
U.S. FDA Resources

Further study details as provided by Theraclone Sciences, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK) and immunogenicity of TCN-032 [ Time Frame: up to 28 days after viral challenge ] [ Designated as safety issue: Yes ]
  • Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28. [ Time Frame: 28 days after viral challenge ] [ Designated as safety issue: No ]
  • Development of viral resistance to TCN-032 [ Time Frame: up to 9 days after viral challenge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The duration of influenza symptoms or pyrexia [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • The time to peak of influenza symptoms or pyrexia [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • The daily incidence of influenza symptoms or pyrexia. [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The proportion of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The duration of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The time to peak of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The daily incidence of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The peak value of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • The time to peak of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • The duration of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • The daily incidence of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • The AUC of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The peak value of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The time to peak of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The duration of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The daily incidence of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Incidence of seroconversion to viral challenge strain [ Time Frame: up to 28 days after viral challenge ] [ Designated as safety issue: No ]
  • Incidence of seroprotection to viral challenge strain [ Time Frame: up to 28 days after viral challenge ] [ Designated as safety issue: No ]
  • Total tissue count and total mucus weight after viral inoculation [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TCN-032
single-dose, administered intravenously
 Biological: TCN-032
Placebo Comparator: Placebo (saline)
single-dose, administered intravenously
 Biological: Placebo (saline)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719874

Contacts
Contact: Jennifer L. Mitcham 206-805-1608 jmitcham@theraclone-sciences.com
Contact: Teri D. Koller 206-805-1635 tkoller@theraclone-sciences.com

Locations
United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Theraclone Sciences, Inc.
Investigators
Study Director: Eleanor L Ramos, MD Theraclone Sciences, Inc.
  More Information

No publications provided

Responsible Party: Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01719874     History of Changes
Other Study ID Numbers: TCN-032-002
Study First Received: October 25, 2012
Last Updated: October 30, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Theraclone Sciences, Inc.:
Influenza
monoclonal antibody

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013