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    Summary
    EudraCT Number:2017-002028-26
    Sponsor's Protocol Code Number:AK0529-1003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-002028-26
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalised Infants with Respiratory Syncytial Virus Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of AK0529 in infants with Respiratory Syncytial Virus Infection
    A.3.2Name or abbreviated title of the trial where available
    Viral Inhibition in Children for Treatment of RSV (VICTOR)
    A.4.1Sponsor's protocol code numberAK0529-1003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02654171
    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 SponsorArk Biosciences Pty Ltd.
    B.1.3.4CountryAustralia
    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 supportArk Biosciences Pty Ltd.
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArk Biosciences Pty Ltd.
    B.5.2Functional name of contact pointJim Wu
    B.5.3 Address:
    B.5.3.1Street Address3/321 Chapel Street, Prahran
    B.5.3.2Town/ cityVictoria
    B.5.3.3Post code3181
    B.5.3.4CountryAustralia
    B.5.4Telephone number8613681968024
    B.5.5Fax number862158350137
    B.5.6E-mailjim.wu@arkbiosciences.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.3.2Product code AK0529
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAK0529
    D.3.9.2Current sponsor codeAK0529
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4
    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.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) 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Syncytial Virus Infection
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus Infection
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial 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
    To evaluate the safety and tolerability of single and multiple oral doses of AK0529 in infants hospitalised with RSV
    E.2.2Secondary objectives of the trial
    To characterise the single and multiple dose pharmacokinetics of AK0529 in infants hospitalised with RSV.
    To determine the antiviral effects in infants hospitalised with RSV by measuring the RSV viral load (VL) area under the curve (AUCElast) in nasal, pharyngeal and tracheal washes / aspirates.
    To evaluate the clinical benefit of AK0529 by determination of the RSV Related Signs and Symptom Scores of infants hospitalised with RSV; additional clinical endpoints will be assessed including:
    Time to return to participation in usual activities
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients of any race or ethnicity with an age adjusted for any prematurity [10] of ≥1 month and ≤24 months.
    2. Diagnosis of RSV infection by virological means, which may include rapid diagnostic point of care testing, within 96 hours preceding screening for Part 1 and 72 hours for Part 2.
    3. Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles (inclusive) for the patient's age, based on the local child growth standards
    4. The parent / legal guardian of the patient must have provided written informed consent for the patient to participate.
    5. For patients aged <12 months, and occipito-frontal head circumference (OFHC) within the normal range for age and gender.
    E.4Principal exclusion criteria
    1. The patient has taken, is currently taking or requires any restricted medications.
    2. Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months).
    3. Participation in an investigational drug or device study within 30 days prior to the date of screening.
    4. Requires vasopressors or inotropic support at the time of enrolment.
    5. Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
    6. Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrolment. However, any ventilation
    as the result of RSV illness is acceptable.
    7. Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia).
    8. Left to right shunt meriting corrective therapy.
    9. Renal failure including renal anomalies likely to be associated with renal insufficiency (e.g. clinical conditions of renal dysplasia, polycystic renal disease, renal agenesis).
    10. Clinical evidence of hepatic decompensation e.g. hepatic disorder with associated coagulopathy or associated encephalopathy).
    11. Cerebral palsy with microcephaly, chronic or persistent feeding difficulties or seizures.
    12. Symptomatic because of inborn errors of metabolism (e.g. mitochondrial disorders, disorders of carbohydrate metabolism, glycogen storage disorders).
    13. Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinaemia, common variable immunodeficiency, immunosuppressive therapy other than glucocorticoid or monteleukast therapy forming part of care directed by the treating physician).
    14. For Part 2 of this study, children with a history of having received palivizumab or any other monoclonal agent directed against RSV in the preceding 120 days. This exclusion criterion does not apply to Part 1.
    15. Evidence of active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrolment.
    16. A history of epilepsy or seizures including febrile seizures.
    17. Allergy to test medication or constituents.
    18. Weight less than 10th percentile or greater than 90th percentile for age and gender adjusted for any prematurity.
    19. The patient’s parent or legally acceptable representative is an employee of the investigator or the study center, with direct involvement in the proposed study or other studies under the direction of that investigator of the study center, or any family members of the employees or the investigator.
    20. Failure to satisfy the investigator of fitness to participate for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability parameters will be assessed:
    Laboratory tests (haematology, chemistry, and urinalysis test results), and changes from Baseline in these parameters, at each predefined time point.
    ECG measures summarised by the observed data and changes from Baseline in these parameters, at pre-defined time points.
    Vital sign parameters (systolic and diastolic blood pressure, temperature, respiration rate, and heart rate), and changes from Baseline in these parameters, at predefined time points.
    Incidence of AEs, serious AEs (SAEs), and withdrawals due to AEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline, evaluations will be made throughout the course of the study, including following discharge from hospital.
    E.5.2Secondary end point(s)
    Pharmacokinetic parameters for AK0529:
    Plasma concentrations, mean, standard deviation, coefficient of variation, geometric mean, median, minimum, and maximum.
    AUC0-∞, CL/F, Vc/F and C12 and Cmax.
    Population pharmacokinetics (POP-PK) to assess the appropriateness of the selected dose level will be performed using Cmax, AUC0-∞ and C12 for the first three patients enrolled (two on active AK0529), and similarly, with the data for each subsequent patient on active AK0529.
    Additional pharmacokinetic parameters may also be derived for patients with extensive PK sample collection.

    AUC change of VL from baseline through IMP last administration:
    For individual patients with samples obtained from the respiratory tract pre-dose and post-dose in specimens of the same nature e.g. nasal swab, nasopharyngeal aspirate. Based on AUC from baseline to last administration of study medication (Day 5).

    To determine RSV genome sequence and determination of RSV genotype, subtype and RSV F gene sequence from the clinical specimens

    Additional statistical variables may be determined as appropriate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline, evaluations will be made throughout the course of the study, including following discharge from hospital.
    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 Yes
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Hong Kong
    Israel
    Lebanon
    Malaysia
    Poland
    Taiwan
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    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
    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 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 months7
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 48
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 48
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    F.3.2Patients Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients of ≥1 month and ≤24 months of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 48
    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)
    normal treatment - standard of care
    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 Decision2018-03-12
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-09
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