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    Summary
    EudraCT Number:2017-005062-21
    Sponsor's Protocol Code Number:MK1654-002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-11-15
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-005062-21
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK 1654 in Pre-Term and Full-Term Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1b Study of MK-1654 Safety and PK in Pre-Term and Full-Term Infants
    A.4.1Sponsor's protocol code numberMK1654-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03524118
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/554/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme LLC
    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 supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC
    B.5.2Functional name of contact pointAndrew Lee
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Avenue P.O. Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.6E-mailandrew_wen-tseng_lee@merck.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 MK-1654
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMK-1654
    D.3.9.2Current sponsor codeMK-1654
    D.3.9.3Other descriptive nameAnti RSV F antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lower respiratory tract infections (LRI) caused by respiratory syncytial virus (RSV) A and B strains
    E.1.1.1Medical condition in easily understood language
    This trial indication is RSV (a common respiratory virus)
    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 LLT
    E.1.2Classification code 10039247
    E.1.2Term RSV infection
    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
    To evaluate the safety and tolerability of MK-1654 through Day 365
    E.2.2Secondary objectives of the trial
    1. To estimate the serum pharmacokinetic (PK) profile of MK-1654 on Days 7, 14, 90, 150, and 365
    2. To describe the incidence of anti-drug antibodies (ADAs) to MK-1654 on Days 14, 90, 150, and 365
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood, serum) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questionsnot described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time
    E.3Principal inclusion criteria
    1. Be healthy (based on screening safety laboratory, medical history, and physical examination results) participants
    2. Participant is Male or Female
    3. Participant is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records.
    4. Participant has chronological age between 2 weeks and 8 months (inclusive) at the time of signing the informed consent
    5. Participant weighs at least 2 kg at the time of screening
    6. The participant’s legally acceptable representative provides written informed consent for the study. The participant’s legally acceptable representative may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research
    E.4Principal exclusion criteria
    1. Has been recommended to receive palivizumab per local standard of care
    2. Has one or more documented out-of-range safety laboratory results, adjusted for age:
    a. Serum Cr >2.0 x upper limit of normal (ULN) for age [Mayo Medical Laboratories 2018]
    b. AST/ALT >2.0 X ULN [Mayo Medical Laboratories 2018]
    c. Hb <9.0 g/dL [Unbound Medicine 2018]
    d. WBC <4000 cells/mm3
    e. Platelets <120,000 mm3
    3. Has a known hypersensitivity to any component of the RSV monoclonal antibody
    4. Has a history of congenital or acquired immunodeficiency (eg, splenomegaly)
    5. Has documented human immunodeficiency virus (HIV) infection.
    6. Has documented hepatitis B (HBsAg+) or hepatitis C (HCV RNA+) infection.
    7. Has known history of functional or anatomic asplenia
    8. Has a recent (within 14 days prior to screening) diagnosis of failure to thrive
    9. Has known or history of a coagulation disorder contraindicating intramuscular injection
    10. Has received or is expected to receive blood products (except irradiated platelets) within 3 months prior to enrollment.
    11. Has prior known documented RSV infection.
    12. Has hemodynamically significant congenital heart disease.
    13. Has chronic lung disease of prematurity requiring ongoing medical therapy.
    14. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere
    with the participant’s participation for the full duration of the study.
    15. Has any history of malignancy prior to randomization.

    If any of the following Medical Conditions criteria apply, the Day 1 Visit may be rescheduled for a time when these criteria are not met:
    16. Has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or
    axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
    17. Is not up-to-date on required vaccinations per local pediatric vaccine schedule at time
    of screening.
    18. Has received inactivated or component vaccines (eg, influenza, hepatitis B) less than
    14 days pre-dose.
    19. Has received live, attenuated, non-study licensed pediatric vaccines (eg, Bacillus Calmette–Guérin vaccine) less than 30 days pre-dose.

    Prior/Concomitant Therapy
    20. Prior administration of any vaccine or monoclonal antibody (mAb) for the prevention of RSV

    Prior/Concurrent Clinical Study Experience
    21. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor.
    22. Has enrolled previously in the current study and been discontinued.
    23. Participant’s mother participated in RSV vaccine clinical study while pregnant and participant is 3 months or less in chronological age.

    Other Exclusions
    24. Is unable to provide blood sample at screening.
    25. Cannot be adequately followed for safety according to the protocol plan.
    26. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
    27. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
    28. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
    E.5 End points
    E.5.1Primary end point(s)
    - Solicited injection site adverse events (AEs) Day 1 through Day 5 post-dose
    - Solicited systemic AEs Day 1 through Day 5 post-dose
    - Serious adverse events (SAEs) from Day 1 through Day 365 post-dose
    E.5.1.1Timepoint(s) of evaluation of this end point
    There is an interim analysis planned to evaluate PK and safety data once Panels A-C complete their day 150 visit
    E.5.2Secondary end point(s)
    - The MK-1654 PK variable(s) AUC0-inf, Cmax, Tmax, t1/2, C7days, C14days, C90days, C150days and C365days
    - Titer of ADAs to MK-1654 on Days 14, 90, 150, and 365
    E.5.2.1Timepoint(s) of evaluation of this end point
    The serum pharmacokinetic (PK) profile of MK-1654 on Days 7, 14, 90, 150, and 365
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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
    Study to evaluate Safety, Tolerability and Pharmacokinetics
    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.8.2.4Number of treatment arms in the trial6
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Chile
    Colombia
    Korea, Republic of
    South Africa
    United States
    Estonia
    Spain
    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.8.9.2In 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: 180
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 90
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 90
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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