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    Summary
    EudraCT Number:2006-006902-27
    Sponsor's Protocol Code Number:ALN-RSV01-105
    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:2008-12-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-006902-27
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety and efficacy of intranasal ALN-RSV01 administered to adult volunteers experimentally inoculated with Respiratory Syncytial Virus
    A.4.1Sponsor's protocol code numberALN-RSV01-105
    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 SponsorAlnylam Pharmaceuticals, 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 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 nameALN-RSV01
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Experimentally induced Respiratory Syncytial Virus infection. The experimental infectious dose has been titrated in a previous study in healthy volunteers.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052200
    E.1.2Term Respiratory syncytial virus infection NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of the safety and tolerability of intranasal ALN-RSV01 versus placebo, administered in a multiple-dose schedule (once daily for 5 days) to healthy adult volunteers experimentally inoculated with respiratory syncytial virus (RSV).
    E.2.2Secondary objectives of the trial
    Determination of the the impact of ALN-RSV01 on symptoms of RSV infection, RSV infection rate based on measures of viral load, and understanding the potential antiviral activity of ALN-RSV01.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males 18 to 45 years of age, inclusive.
    2. Availability for the required study period (including the inpatient quarantine phase), ability to comply with study requirements, and ability to attend the scheduled inpatient (quarantine) and follow-up study visits.
    3. Able to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
    4. Good general health status as determined by a screening evaluation no greater than 120 days but not less than 14 days prior to enrollment and admission to the quarantine unit.
    5. Agreement to use condoms as a barrier method of birth control for any sexual contact for 30 days after the last dose of study medication.
    6. Has a body mass index (BMI) greater than 18.0 and that is considered by the Investigator as clinically acceptable for the subject.
    7. Low titers of RSV neutralizing antibody measured during Screen.
    E.4Principal exclusion criteria
    1. Females are not eligible for this study.
    2. Positive serologic test for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody positive.
    3. Evidence of or history of drug or alcohol abuse (within the past 6 months) or a positive urine drug or alcohol screen.
    4. An abnormal ECG deemed clinically relevant by the PI.
    5. Subjects unable or unwilling to refrain from smoking or using tobacco products during the quarantine period
    6. Has current seasonal allergic rhinitis (SAR), or recent viral rhinitis within 4 weeks prior to study drug administration.
    7. Allergy to gentamycin or other aminoglycoside antibiotics.
    8. Has any nasopharyngeal abnormality that may interfere with absorption, distribution, or study-related evaluations as judged by the PI
    9. Presence of household member or close contact to someone who
    a. is less than three (3) years of age
    b. has a known immunodeficiency
    c. is receiving immunosuppressant drugs
    d. is undergoing or soon to undergo cancer chemotherapy within 28 days of challenge
    e. has diagnosed emphysema, chronic obstructive pulmonary disease (COPD), or severe lung disease
    f. is elderly and residing in a nursing home, or
    g. has received an organ transplant.
    10. Any laboratory test which is abnormal and deemed by the investigator to be clinically significant. (This includes blood chemistry, hematology, or urinalysis).
    11. Presence of any febrile illness or symptoms suggestive of viral respiratory infection within 4 weeks prior to challenge.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints will evaluate the tolerability of ALN-RSV01 relative to placebo in RSV-exposed individuals, and will include the following:
    • Frequency and severity of treatment related adverse events
    • Treatment-related changes in vital signs
    • Treatment-related changes in physical examination (PE) findings
    • Treatment-related changes in nasal examination findings
    • Treatment-related changes in electrocardiogram (ECG) parameters
    • Treatment-related changes in clinical laboratory assessments.
    Efficacy endpoints are exploratory and may include
    • Changes in symptoms of RSV infection
    • Frequency of RSV infection, expressed as the percentage of subjects developing infection after inoculation.
    • Assessment of RSV viral load
    a. Peak amount of viral load
    b. Time to peak viral load
    c. Mean daily viral load
    d. Duration of viral shedding
    e. Overall viral load (based on the area under the concentration-time curve [AUC])
    • Serum RSV antibody response
    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 No
    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 Yes
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state88
    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 Decision2007-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-12
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