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    The EU Clinical Trials Register currently displays   43602   clinical trials with a EudraCT protocol, of which   7206   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-001107-20
    Sponsor's Protocol Code Number:MDT-637-CP-201
    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:2013-07-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-001107-20
    A.3Full title of the trial
    A Phase 2a Randomised, Double-Blind, Placebo-Controlled Repeat Dose Trial of the Activity of MDT-637 in Healthy Subjects Challenged with RSV-A (Memphis 37b)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a trial that is studying a new inhaled medicine, MDT-637, that is being researched for the treatment of a viral infection of the lungs that typically affects the young and the elderly (Respiratory Syncytial Virus, RSV). Adult volunteers will be infected with RSV (the infection is typically mild in adults), half of these volunteers will be treated with MDT-637, and the other half will receive placebo which has no effect on RSV.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2a trial of MDT-637 in healthy subject challenged with RSV.
    A.4.1Sponsor's protocol code numberMDT-637-CP-201
    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 SponsorMicroDose Therapeutx, Inc., a wholly owned subsidiary of Teva Pharmaceuticals Industries, Ltd.
    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 supportMicroDose Therapeutx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMicroDose Therapeutx, Inc.
    B.5.2Functional name of contact pointRobert Cook, Ph.D MRPharmS
    B.5.3 Address:
    B.5.3.1Street Address4262 Route 1, Monmouth Junction
    B.5.3.2Town/ cityNew Jersey
    B.5.3.3Post codeNJ 08852-1947
    B.5.3.4CountryUnited States
    B.5.4Telephone number17323552144
    B.5.5Fax number17323552101
    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 nameMDT-637
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 235106-62-4
    D.3.9.2Current sponsor codeMDT-637
    D.3.9.3Other descriptive nameVP 14637
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    RSV Infection
    E.1.1.1Medical condition in easily understood language
    Respiratory infection with respiratory syncytial virus (RSV)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10038717
    E.1.2Term Respiratory syncytial viral infections
    E.1.2System Organ Class 100000004862
    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 efficacy objective and endpoint of the study is to evaluate the antiviral effect (as defined by reduction in AUC of viral load) of aerosolized MDT-637, in a manner which mimics the timing of the infection and potential treatment application in infants and children.

    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives include:
     - Virology
    o Antiviral effect (as defined by reduction in log AUC viral load by TCID50)
    o Duration and peak of virus shedding
     - Clinical
    o The reduction in nasal mucous production
    o The reduction in symptom scores
     - Device
    o Performance of the EPIC Inhaler

    The safety objectives are:
     - To evaluate the safety profile of MDT-637 in the RSV-A (Memphis 37b) infected human respiratory tract.
     - To determine the safety of the inhaler device

    The exploratory objectives are:
     - To investigate the potential for the development of viral resistance.
     - To determine the quality of sleep
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    3. A Total body weight ≥50kg and a BMI >18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female).
    4. (a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 28 follow-up visit.
    (b) In addition, male subjects must not donate sperm following discharge from Quarantine until the Day 28 follow-up visit.
    (c) Female subjects must be either:
    - post-menopausal (defined as at least one year documented history without any menses/or post-menopausal females (confirmed by FSH test) prior to Screening or
    - documented status as surgically sterile or post hysterectomy or
    - if of childbearing potential, must have a negative urine pregnancy test at SSS and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 28 follow-up visit.
    Acceptable forms of effective contraception include:
    - Established use of oral, injected or implanted hormonal methods of contraception
    - Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    - Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    - Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised male partner should be the sole partner for that subject].
    5. An informed consent document voluntarily signed and dated by the subject and investigator
    6. Sero-suitable for Challenge Virus
    E.4Principal exclusion criteria
    1. Subjects who have a significant history of any tobacco use at any time (≥ total 10 pack year history)
    2. Subjects who are pregnant or breast feeding; or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period
    3. Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the medical investigator.
    Eczema/Atopic Dermatitis: subjects with clinically mild eczema/atopic dermatitis may be included at the Investigator's discretion.
    Psoriasis: patients with active psoriasis affecting less than 5% of the body's surface area for the past five years can be included at the Investigator's discretion. Patients with a history of completely resolved guttate psoriasis can be included.
    Subjects with a diagnosis of a single mild or moderate depressive episode two or more years ago, with good evidence of preceding stressors and which resolved within approximately three months, may be included at the Investigator's discretion.
    4. Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities in spirometry.
    5. History or evidence of autoimmune disease or known immunodeficiency of any cause.
    6. Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology.
    7. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Patients with a single episode of wheezing after age 12 (lasting less than eight weeks) can be included at the Investigator's discretion provided the episode is more than four years ago and did not require a hospital admission and/or oral steroids.
    8. Positive HIV, hepatitis B , or hepatitis C test.
    9. Any significant abnormality altering the anatomy of the nose or nasopharynx.
    10. Any clinically significant history of epistaxis.
    11. Any nasal or sinus surgery within 6 months of inoculation.
    12. Recurrent history of clinically significant autonomic dysfunction.
    13. Any laboratory test or ECG, which is abnormal and deemed by the investigator(s) to be clinically significant.
    14. Confirmed positive test for cotinine and /or drugs of abuse deemed by the Investigator to be clinically significant.
    15. Unable to comply with study procedures including venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
    16. Any known allergies to the excipients in the Challenge Virus inoculum or investigational product. Specifically severe lactose intolerance.
    17. Health care workers who work in units with severely immuno-compromised patients.
    18. Presence of household member or close contact (for an additional two weeks after discharge from the isolation facility) who:
    has known immunodeficiency
    is receiving immunosuppressant medication
    is undergoing or soon to undergo cancer chemotherapy within 28 days of viral inoculation
    has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home.
    has received a bone marrow or solid organ transplant
    19. Evidence of vaccinations within the four weeks prior to Human Viral Challenge. Intention to receive travel vaccination(s) before the Day 28 Follow Up Visit.
    20. Those employed or immediate relatives of those employed at RVL or the Sponsor.
    21. Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the 3 months prior to inoculations.
    22. Use within 28 days prior to Human Viral Challenge (Day 0) of nasal steroids. Use of any prescription medication within 14 days of Day -2 or over-the-counter preparations, within 5 days of Day -2 for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infection deemed by the Investigator to be clinically significant.
    23. For investigational products, receipt of small molecule product within 3 months or a biological product within 12 months prior to inoculation. Prior participation in a clinical trial with the same strain of respiratory virus. Participation in any other Human Viral Challenge Study with a respiratory virus within one year prior to the day of inoculation/first dosing with IMP.
    24. Receipt of systemic: glucocorticoids, antiviral drugs, or Igs or any other cytotoxic or immunosuppressive drug within 6 months prior to dosing. Receipt of any systemic chemotherapy agent at any time.
    25. Presence of significant respiratory symptoms existing on the day of challenge or between admission to the unit and inoculation with virus. History suggestive of respiratory infection within 14 days prior to admission to the unit.
    26. Any other finding that, in the opinion of the Investigator or Sponsor, deems the subject unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to evaluate the antiviral effect (as defined by reduction in AUC of viral load) of aerosolized MDT-637, in a manner which mimics the timing of the infection and potential treatment application in infants and children.
    This will be measured by analysing the area under the curve (AUC) for each subject via Quantitative Polymerase Chain Reaction Viral Load.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Frequency and method:

    The Viral load will be detected and quantified in using aliquots from the nasal wash samples taken twice a day from Quarantine Day 1 post inoculum through to Day 12. The samples will be processed by Retroscreen Laboratories and shipped to Sponsor designated
    laboratory in two separate batches per quarantine for analysis.
    E.5.2Secondary end point(s)
    The secondary efficacy objectives include:
    - Virology
    o Antiviral effect (as defined by reduction in log AUC viral load by TCID50)
    o Duration and peak of virus shedding
    - Clinical
    o The reduction in nasal mucous production
    o The reduction in symptom scores
    - Device
    o Performance of the EPIC Inhaler
    E.5.2.1Timepoint(s) of evaluation of this end point
    The Time point of evaluation of this end points will be evaluated by Nasal wash for Virology and Virus shedding twice daily on Day 1 to day 12 Post-Inoculation. The time point for evaluation using viral serology is Day -2 and Day 28.

    The Time point of evaluation of Nasal mucous production is Once daily on Day 1 to Day 12 post-Inoculation.
    The Time point of Symptom scores is Four times daily on Day 1 to Day 12 Post-Inoculation.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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. 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
    The End of Trial is defined as the last scheduled visit for the last subject (LSLV). If a safety visit is required after the last scheduled visit, this will be scheduled based upon the CI’s discretion as a duty of care and in line with ICH-E6 Section 4.3.2 e.g. repeat spirometry or laboratory tests. However, to achieve the objectives of the research, these discretionary follow up visits will not be considered part of the trial data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 96
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state96
    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)
    It is not expected that the subjecs will need any further monitoring or clinical interventions once the study has finished. A follow-up visit at approx. study day 28 will assess if the subjects have had any ongoing health problems that may be attributed to their participation in the study. Subjects will be given details of a 24 hour Retrosceen contact (emergency card) should problems arise during the study. Study drug will not be made available to participants once the research is finished.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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