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    Summary
    EudraCT Number:2008-000474-20
    Sponsor's Protocol Code Number:AA/JDW/P2_S1_RXQ/288
    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:2009-01-09
    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 number2008-000474-20
    A.3Full title of the trial
    Safety and Efficacy of HT61 (1%) gel applied once or three times for the eradication of nasal Staphylococcus aureus carriage in twelve subjects. A single- blinded, vehicle- controlled, single centre, one week proof of concept study
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of HT61 gel, compared to gel vehicle for MRSA treatment
    A.4.1Sponsor's protocol code numberAA/JDW/P2_S1_RXQ/288
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHelperby Therapeutics Ltd
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameHT61 (1%) gel
    D.3.2Product code HY50A
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Nasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHT61
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Staphylococcus aureus carriage.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058588
    E.1.2Term Bacterial culture positive
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of either once only treatment or three consecutive treatments at one and half hour intervals, with 70 μl of HT61 (1%) gel or vehicle in each anterior nares of the nostril in a panel of twelve subjects, with sensitive or resistant nasal carriage of Staphylococcus aureus.
    E.2.2Secondary objectives of the trial
    To determine the safety and local tolerability of either once only treatment or three consecutive treatments at one and half hour intervals with 70 μl of HT61 (1%) gel or vehicle in each nostril in a panel of twelve subjects with nasal carriage of Staphylococcus aureus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 to 80 years
    2. Following verbal & written information about the trial, the subject has signed & dated informed consent before any study related activity was carried out.
    3. Subject legally competent and able to communicate effectively with the study personnel
    4. Male subject should be abstinent or should be using an effective method of contraception, or partner(s) should be post-menopausal or have a hysterectomy or should use an effective method of contraception. Female subjects should be post menopausal or post –hysterectomy.
    5. Microbial diagnosis of nasal carriage of Staphylococcus aureus.
    6. Treatment area amenable to topical treatment.
    E.4Principal exclusion criteria
    1. Presence of any skin or other condition or disorder that may affect the conduction or outcome of the study
    2. Clinical Signs of infected skin diseases, e.g. infected Eczema
    3. Carriage of either methicillin sensitive or resistant Staphylococcus aureus in the throat
    4. Abnormal pathology of nasal passages
    5. Any clinically significant allergy or drug intolerance
    6. Active hay fever, on-going cold/flu symptoms, including rhinitis
    7. Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics
    8. Known or suspected severe renal insufficiency or severe hepatic disorders.
    9. Subject with history/signs/symptoms of cancer, including melanoma skin cancers, but excluding other skin cancers
    10. Current participation or within less than 30 days in any other interventional clinical trial.
    11. Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units. One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine.
    12. Subjects with known or suspected immunodeficiency.
    13. Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit
    14. intranasal steroids for rhinitis
    15. Subjects who have received treatment with any non–marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to baseline visit
    16. Current history or presence of clinically significant haematological, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, or neurological disease
    17. Blood donation or blood loss of more than 600 ml within 90 days prior to dosing on Day 1.
    18. Known or suspected drug abuse.
    E.5 End points
    E.5.1Primary end point(s)
    1. Levels of absorbed HT61 in blood plasma at baseline and after 30min, 1h, 2h, 4h, 6h (single application only), 1d, 2d and 7 days after the last application of the investigational medicinal product.
    2. Adverse events (AEs) will be monitored throughout the study
    3. Pathology of the nasal passages assessed by an ENT specialist at specified time points as outlined in study flow charts A and B
    4. ECG;s and vital signs at specified time points as outlined in study flow charts A and B
    5. Effect of HT61 on clinical chemistry and liver function at specified time points as outlined in study flow charts A and B.
    6. Urinalysis at specified time points as outlined in study flow charts A and B.
    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 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.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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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.8.3 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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state12
    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 Decision2008-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-08
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