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    Summary
    EudraCT Number:2012-000854-73
    Sponsor's Protocol Code Number:TCN‐032‐002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-000854-73
    A.3Full title of the trial
    A PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TCN-032 (HUMAN MONOCLONAL ANTIBODY DIRECTED AGAINST THE M2 PROTEIN OF INFLUENZA A VIRUS) IN SUBJECTS CHALLENGED WITH H3N2 INFLUENZA A VIRUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza (Flu).
    A.3.2Name or abbreviated title of the trial where available
    Study to Test TCN-032 as a Treatment for Influenza.
    A.4.1Sponsor's protocol code numberTCN‐032‐002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTHERACLONE SCIENCES, INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTHERACLONE SCIENCES, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRetroscreen Virology Limited
    B.5.2Functional name of contact pointCharmaine O'Neil
    B.5.3 Address:
    B.5.3.1Street AddressQueen Mary BioEnterprises, Innovation Centre, 42 New Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE1 2AX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207691 0981
    B.5.5Fax number00440203070 0013
    B.5.6E-mailc.oneill@retroscreen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTCN-032
    D.3.2Product code TCN-032
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeTCN-032
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of severe influenza A virus disease.
    E.1.1.1Medical condition in easily understood language
    Treatment of severe influenza (flu).
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10070215
    E.1.2Term Influenza A virus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of influenza symptoms Grade 2 or higher, or pyrexia, from Day 1 to Day 7, after viral challenge.
    E.2.2Secondary objectives of the trial
    Evaluate effect of TCN-032 vs. placebo in nasal virus AUC (viral culture, D1-7).
    Additional objectives- evaluation of:
    • Duration, time to peak, daily incidence of influenza symptoms ≥Grade 2, or pyrexia
    • Proportion (D1-7), duration, time to peak, daily incidence of components of primary objective: Upper & Lower respiratory & systemic influenza symptoms and pyrexia
    • Proportion (D1-7), duration, time to peak, daily incidence of any grade influenza symptoms, or pyrexia
    • Mucus weight (D1-7)
    • Peak value, time to peak, duration &daily incidence of virus shedding from nasal mucosa (viral culture)
    • AUC (D2-7), peak value, time to peak, duration & daily incidence of virus shedding from nasal mucosa (qPCR)
    • PK & immunogenicity of TCN-032
    • Seroconversion and seroprotection to viral challenge strain
    • Change in HAI titre pre-challenge to D28
    • Viral resistance to TCN-032
    Evaluate safety of subjects who undergo viral challenge, with or without TCN-032 treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be considered eligible if they satisfy all of the following inclusion criteria:
    1. Age 18 to 45 years, inclusive.
    2. In good health with no history of major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator by a screening evaluation no greater than 45 days prior to inoculum.
    3. Body weight between 50 and 100 kg, inclusive (body mass index [BMI] >18 kg/m2 to <33 kg/m2).
    4. Female subjects must not be pregnant or nursing and must either be of non-childbearing potential (e.g. surgically sterile) or agree to use reliable contraceptive practices as in Table 2 (2 methods must be used) should they be heterosexually active. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy tests and subjects must refrain from becoming pregnant until 4 months after IMP dosing. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female condoms and male condoms should not be used together as friction between the two can result in either product failing. Postmenopausal: Female subjects who have been amenorrheic for at least 2 years and have a serum follicle-stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females.
    5. For non-sterilised male subjects who are heterosexually active, agreement to use 2 effective forms of birth control from admission into quarantine, and refrain from fathering a child at least until 4 months after the IMP dosing. Female condoms and male condoms should not be used together as friction between the two can result in either product failing. If a male subject has had a vasectomy (with a negative sperm post-vasectomy semen analysis) 6 months or greater before the Screening Visit, one additional contraception method is required until 4 months after dose of IMP.
    6. Willingness to provide written consent for participation after reading the Subject Information Sheet and Consent Form and after having adequate opportunity to discuss the study with an Investigator. Comprehension of the study requirements; availability for the required study period, ability to attend scheduled study visits, and willingness to participate in the quarantine stay.
    7. Serosusceptible (HAI titre <10) to the challenge virus at all visits prior to admission into quarantine.
    8. Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza-like illness in the current season, defined as in the last 12 months prior to screening.
    9. Should have a negative cotinine test on Day –2. However if a subject has a positive test on Day –2, then a repeat test on Day –1 or Day 0 must be negative.
    10. Non smoker or current smoker willing/able to desist for the quarantine phase of the study or anyone who has a cumulative smoking history of ≤ 5 pack years.
    E.4Principal exclusion criteria
    1. Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
    2. History of autoimmune disease
    3. History of adulthood asthma/chronic lung condition
    4. History of recurrent lower respiratory tract infection or lower respiratory tract infection within 3 months of study
    5. Positive for HIV, HBV or HCV
    6. Subject is diabetic
    7. Anatomic or neurologic abnormality impairing gag reflex
    8. History of frequent epistaxis
    9. Known IgA deficiency, immotile cilia syndrome or Kartageners syndrome
    10. Nasal or sinus surgery within 6 months of study
    11. Recent and/or recurrent history of autonomic dysfunction
    12. Abnormal laboratory test deemed clinically significant
    13. Abnormal ECG or abnormal spirometry deemed clinically relevant
    14. Acute medical condition or significant past medical history of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic, endocrine, or other diseases
    15. Major surgery within 3 months of study
    16. Evidence of drug abuse or positive urine Class A drug or alcohol screen
    17. Venous access deemed inadequate
    18. Subjects symptomatic with hay fever on admission into the unit for quarantine session or prior to viral inoculation will be excluded.
    19. History of significant adverse reactions or allergies
    20. History of allergy or intolerance to oseltamivir or zanamivir.
    21. Health care workers
    22. Presence of household member or close contact (for 2 weeks after discharge) who is at risk of contracting influenza
    23. Intending to travel within the next 3 months
    24. Employed or immediate relatives of those employed at RVL or Sponsor.
    25. Receipt of blood or blood products or loss of >450 mL of blood within 3 months of study
    26. Acute use of medication for rhinitis or nasal congestion within 1 week of study
    27. Use of prescription drugs, herbal supplements, within 4 weeks of study at the discretion of the Investigator in conjunction with TCN
    28. Chronic use of any medication for rhinitis/nasal congestion or chronic nasopharyngeal complaint
    29. Receipt of any investigational drug within 3 months of study or prior participation in a clinical trial of influenza vaccine, experimental influenza viral challenge or other respiratory virus challenge within 1year prior study
    30. Receipt of antiviral drugs within 1 month of study
    31. Receipt of systemic glucocorticoids, immunoglobulins (Igs), other cytotoxic/immunosuppressive drugs, or systemic chemotherapy agent
    32. Previous treatment with monoclonal antibodies
    33. Presence of febrile illness/symptoms of viral respiratory infection within 2 weeks prior study
    34. Physical examination or screening investigations which lead the Investigator(s) to consider the subject unfit for the study
    35. Subjects, who in the opinion of their General Practitioner or the Chief Investigator or designee, should not participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects who develop influenza symptoms Grade 2 or higher, or pyrexia, from Day 1 to Day 7, after influenza A viral challenge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 7.
    E.5.2Secondary end point(s)
    The main secondary endpoint is the total virus shedding (AUC) from the nasal mucosa, measured by viral culture, from Day 1 to Day 7, after influenza A viral challenge.
    Additional secondary endpoints include:
    • The duration, time to peak, and daily incidence of influenza symptoms Grade 2 or higher, or pyrexia
    • The proportion (from Day 1 to Day 7), duration, time to peak, and daily incidence of the components of the primary endpoint:
    o Upper respiratory symptoms
    o Lower respiratory symptoms
    o Systemic influenza symptoms
    o Pyrexia
    • The proportion (from Day 1 to Day 7), duration, time to peak, and daily incidence of any grade influenza symptoms, or pyrexia
    • Mucus weight (from Day 1 to Day 7) assessed by paper tissue weights
    • The peak value, time to peak, duration, and daily incidence of virus shedding from the nasal mucosa measured by viral culture
    • The AUC (Day 2 to Day 7), peak value, time to peak, duration, and daily incidence of virus shedding from the nasal mucosa measured by qPCR
    • PK and immunogenicity of TCN-032
    • Incidence of seroconversion and seroprotection to viral challenge strain
    • Change in HAI titre pre-challenge to Day 28
    • Proportion of subjects who develop viral resistance to TCN-032 (based on changes in TCN-032 binding, sequence changes in M2, ADCC susceptibility of infected cells)

    Safety endpoints:
    Incidence and severity of adverse events, incidence and severity of laboratory changes, changes in vital signs and clinical tests (ECG, spirometry)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 28.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS. However, the duration could, on the rare occasion, extend out to 190 days if the subject should require follow-up ADA samples.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The study duration (not treatment) could, on the rare occasion, extend out to 190 days if the subject should require follow-up ADA samples. Please refer to the protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-01
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