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    Summary
    EudraCT Number:2013-005104-33
    Sponsor's Protocol Code Number:ALS-8176-503
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-10-26
    Trial results View 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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2013-005104-33
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized with Respiratory Syncytial Virus (RSV) Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of ALS-008176 in Infants Hospitalized with RSV
    A.4.1Sponsor's protocol code numberALS-8176-503
    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 SponsorAlios BioPharma
    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 supportAlios BioPharma
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlios BioPharma
    B.5.2Functional name of contact pointNone
    B.5.3 Address:
    B.5.3.1Street Address260 E. Grand Ave
    B.5.3.2Town/ citySouth San Francisco. CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.6E-mailMmcclur3@its.jnj.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 nameALS-008176
    D.3.2Product code ALS-008176
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    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 INNN/A
    D.3.9.1CAS number Pending
    D.3.9.2Current sponsor codeALS-008176
    D.3.9.3Other descriptive nameALS-008176
    D.3.9.4EV Substance CodeSUB120906
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    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 nameALS-008176
    D.3.2Product code ALS-008176
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    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 INNN/A
    D.3.9.1CAS number Pending
    D.3.9.2Current sponsor codeALS-008176
    D.3.9.3Other descriptive nameALS-008176
    D.3.9.4EV Substance CodeSUB120906
    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 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 placeboPowder for oral suspension
    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 (RSV) Infection
    E.1.1.1Medical condition in easily understood language
    Viral Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 doses of ALS-008176
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacokinetics of ALS-008112 and ALS-008144 (and other metabolites, if applicable) in blood following single and multiple doses of ALS-008176
    • To evaluate the antiviral activity of ALS-008176 after single and multiple doses of ALS-008176
    • To determine if ALS-008176 exposure results in the emergence of resistant strains of RSV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subject’s parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
    2) In the investigator’s opinion, the subject’s parent(s)/legal guardian(s) understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
    3) Male or female infant who
    • is ≥ 1.0 to ≤ 12.0 months of age (inclusive), defined at the time of hospital admission
    • has been diagnosed with RSV infection based on study-supplied BINAX NOW RSV test or an RSV PCR or any other RSV assay conducted at the clinical trial site. NOTE: A subject remains eligible if any RSV result is positive. (RSV-specific PCR run locally is strongly encouraged, but not required.) Coinfection with other respiratory viruses or bacterial coinfection in addition to RSV is permissible.
    • has been hospitalized for < 96 hours for confirmed RSV infection (NOTE: nosocomial RSV infection is excluded)
    4) With the exception of the RSV-related illness, the subject is in otherwise good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and ECG
    5. Creatinine clearance is not below the lower limit of normal for the subject’s age (Schwartz equation calculation preferred, however alternative equations may be utilized to determine eligiblity if deemed acceptable by the Investigator and Medical Monitor).
    E.4Principal exclusion criteria
    1) History of or concurrent clinically significant medical illness (not directly attributable to the acute RSV infection) – including, but not limited to cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, immunologic, musculoskeletal, oncologic, or congenital disorders – as judged by the Investigator. Specifically excluded conditions include but are not limited to:
    a. Immunosuppressed state
    b. Bronchopulmonary dysplasia
    c. Congenital heart disease
    d. Down’s syndrome
    2) Prematurity, defined as gestational age < 37 weeks at birth
    3) Subjects receiving invasive endotracheal mechanical ventilation
    4) Subjects who are thought to have a poorly functioning gastrointestinal tract (i.e., unable to absorb drugs or nutrition via enteral route). NOTE: The use of intravenous fluids is not exclusionary so long as the investigator believes the patient’s gastrointestinal tract still functions properly (i.e., is able to absorb drugs or nutrition).
    5) Subjects with clinically significant laboratory abnormalities which are deemed by the Investigator to represent a safety risk to participation in this study. Other laboratory parameters outside the reference range for the subject’s age may be included if the investigator considers the abnormalities unlikely to introduce additional risk factors and will not interfere with data interpretation. A single repeat laboratory evaluation is allowed for eligibility determination.
    6) Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting the study requirements
    7) Clinically significant abnormal ECG findings, as judged by the Investigator
    8) Subjects anticipated to be discharged from the hospital in < 24 hours from the time of randomization
    9) Exclusionary medications include:
    • Herbal supplements which have evidence of adversely affecting absorption and clearance mechanisms (e.g., strong inhibitors/inducers of CYP450) within 21 days prior to randomization
    • The following prescription medications:
    a. Any chronically used, systemic prescription medications
    b. Use of systemic medications (either chronically or within the 21 days prior to randomization) which are known to modulate the host immune response and/or increase viral shedding such as corticosteroids or other immunomodulatory therapies. The only exception is systemic corticosteroids will be acceptable if they are not taken chronically for a non-RSV-related indication.
    c. Prescription medications used within 14 days prior to randomization to treat the RSV infection itself (e.g., ribavirin, intravenous immunoglobulin). Prescription medications intended to treat the symptoms/sequelae of the RSV infection are permitted.
    d. Prescription medications which are known to be a strong inducer or inhibitor of CYP450 enzymes, within 21 days prior to randomization (See Prohibited Medication list in the Study Manual)
    • Investigational drug trial medications within 30 days or 5 half-lives (whichever is longer) prior to randomization
    • Prior exposure to an investigational vaccine
    • MMR vaccine within 1 week prior to screening, according to parent report
    • Prior exposure to ALS-008176
    • Prior exposure to palivizumab
    10. Infants who are breastfeeding and their mother is taking any of the exclusionary medications described in exclusion criterion 9.
    11. Infants with another child in the household who has enrolled in the study
    12. Infants with known fructose intolerance (due to sorbitol in study medication)
    13. Ethnically Japanese infants will not be enrolled outside of Japan
    E.5 End points
    E.5.1Primary end point(s)
    Safety data including, but not limited to, adverse events, physical examinations, vital signs, 12-lead ECGs and clinical laboratory results (including chemistry and hematology)
    E.5.1.1Timepoint(s) of evaluation of this end point
    SAD: Post randomisation, Study days 2 to 6 and Completion visit day 7
    MAD: Post randomisation, Study days 2 to 10, Outpatient safety visit and Completion day 11.
    E.5.2Secondary end point(s)
    PK parameters of ALS-008112 and ALS-008144 (and other metabolites, as applicable) in blood following single dose administration: Cmax, tmax, t1/2, AUC0-24h, AUC0-inf or AUC0-last
    PK parameters of ALS-008112 and ALS-008144 (and other metabolites as applicable) in blood following repeat dose administration: Cmax, Cmin, tmax, t1/2, AUC0-12h, AUC0-24h, AUC0-tau, AUC0-inf or AUC0-last
    RSV viral RNA concentrations in nasal aspirates as measured by quantitative RT-PCR
    Changes in the RSV polymerase that result in reduced sensitivity to ALS-008112
    E.5.2.1Timepoint(s) of evaluation of this end point
    SAD: Post randomisation, Study days 2 to 6 and Completion visit day 7
    MAD: Post randomisation, Study days 2 to 10, Outpatient safety visit and Completion day 11.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First Administration in Paediatric population
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    Chile
    Colombia
    France
    Japan
    New Zealand
    Panama
    Romania
    South Africa
    Taiwan
    Thailand
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    F.1.1Number of subjects for this age range: 264
    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: 264
    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
    Age range; 1.0 to ≤ 12.0 months
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 264
    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)
    None
    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 Decision2015-11-26
    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 Status
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