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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Theraclone Sciences, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719874
First Posted: November 1, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theraclone Sciences, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

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 ]
  • 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. [ Time Frame: 7 days ]
  • The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. [ Time Frame: 7 days ]
  • 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 ]
  • The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. [ Time Frame: 7 days ]
  • The proportion of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ]
  • The duration of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ]
  • The time to peak of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ]
  • The daily incidence of any grade influenza symptoms, or pyrexia [ Time Frame: 7 days ]
  • The peak value of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ]
  • The time to peak of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ]
  • The duration of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ]
  • The daily incidence of virus shedding from the nasal mucosa measured by viral culture [ Time Frame: up to 9 days ]
  • The AUC of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ]
  • The peak value of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ]
  • The time to peak of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ]
  • The duration of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ]
  • The daily incidence of virus shedding from the nasal mucosa measured by qPCR [ Time Frame: 6 days ]
  • Incidence of seroconversion to viral challenge strain [ Time Frame: up to 28 days after viral challenge ]
  • Incidence of seroprotection to viral challenge strain [ Time Frame: up to 28 days after viral challenge ]
  • Total tissue count and total mucus weight after viral inoculation [ Time Frame: 7 days ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01719874     History of Changes
Other Study ID Numbers: TCN-032-002
First Submitted: October 25, 2012
First Posted: November 1, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2012

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
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs