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    EudraCT Number:2018-003347-28
    Sponsor's Protocol Code Number:MK-1654-005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-14
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-003347-28
    A.3Full title of the trial
    A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated with Experimental Respiratory Syncytial Virus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of MK-1654 in healthy volunteers.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2a RSV Human Challenge Study of MK-1654 in Healthy Participants
    A.4.1Sponsor's protocol code numberMK-1654-005
    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 SponsorMerck Sharp & Dohme Corp
    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 Corp
    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 Corp
    B.5.2Functional name of contact pointRegulatory Affairs international
    B.5.3 Address:
    B.5.3.1Street Address351 North Sumneytown Pike
    B.5.3.2Town/ cityNorth Wales
    B.5.3.3Post codePA 19454
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 267 3051697
    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 nameMK-1654
    D.3.2Product code MK-1654
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeMK-1654
    D.3.9.3Other descriptive nameFully human RB-1 YTE anti-RSV F monoclonal antibody (mAb) IgG1
    D.3.9.4EV Substance CodeAS1
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous 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
    RSV is a common virus that can cause severe chest infections in small children, adults with heart, lung and immune system conditions and elderly people.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 determine if a single, intravenous (IV) dose of MK-1654 when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with respiratory syncytial virus subgroup A [RSV A] Memphis 37b) compared to IV placebo
    E.2.2Secondary objectives of the trial
    1. To estimate the effect of each of the 4 dose levels of IV MK-1654 on the incidence of symptomatic RSV infection after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo
    2. To evaluate the safety and tolerability of increasing doses of IV MK-1654 compared to IV placebo
    3. To estimate the MK-1654 serum concentration after administration of increasing doses of IV MK-1654
    4. To estimate RSV serum neutralizing antibody titers after administration of IV MK-1654 compared to IV placebo and after intranasal inoculation (with RSV Memphis 37b)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In good health with no history of major medical conditions that will interfere with subject safety, as defined by medical history, physical examination (including vital signs), ECG, and routine laboratory tests and determined by the Investigator at a screening evaluation.
    2. Participants will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening.

    3. Participant is male or female.
    4. Participant is from 18 years to 55 years of age inclusive, at the time of signing the study specific informed consent.
    5. A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 30kg/m2.

    Male Participants
    Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    6. Male participants must agree to the contraceptive requirements below at dosing and continuing until 90 days after dosing/28 days after viral inoculation – whichever is later.
    • Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male and female) to the IMP.
    • Male sterilisation with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study.
    • In addition, for female partners of child bearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned below for female participants.
    • True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

    In addition to the contraceptive requirements above, male participants must agree not to donate sperm until 90 days after the date of dosing.
    Female Participants
    Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    7. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to dosing.
    Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to dosing. The contraception use must continue until 30 days after dosing/28 days after the date of viral inoculation - whichever is later. Highly effective contraception is as described below:
    • Established (a minimum of 2 weeks prior to dosing) use of hormonal methods of contraception described below.
    1. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    1) oral
    2) intravaginal
    3) transdermal
    2. progestogen-only hormonal contraception associated with inhibition of ovulation:
    1) oral
    2) injectable
    3) implantable
    Note: when hormonal methods of contraception are used, male partners are required to use a condom with a spermicide.

    • intrauterine device (IUD)
    • intrauterine hormone-releasing system (IUS)
    • Bilateral tubal ligation
    • Male sterilisation (with the appropriate written documentation from the participant to confirm the vasectomy) where the vasectomised male is the sole partner for that woman.
    • True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
    8. Female participants who are no longer of child bearing potential.
    • Women no longer of child bearing potential (post-menopausal females are defined as having a history of amenorrhea for at least 12 months with no alternative medical cause, otherwise they should have documented status as being surgically sterile or post hysterectomy (e.g. tubal ligation, hysterectomy, bilateral salpingectomy and bilateral oophorectomy) and/or by FSH level >40 IU/mL, confirmed by laboratory).

    Informed Consent
    9. The participant provides written informed consent/assent for the study, including for future biomedical research.

    Additional Categories
    10. Serosuitable* to the challenge virus within 90 days of IMP dosing.
    * The serology result obtained suggests that the subject is sensitive to RSV infection, i.e. they are likely to be infected following inoculation with the challenge virus.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Females who: Are breastfeeding or have been pregnant within 6 months prior to the study enrollment.
    2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunesuppression), metabolic, urological, renal, neurological, or psychiatric disease (including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis; participants with a history of depression of any severity within the last 2 years prior to IMP dosing should only be included if the PHQ-9 score is less than or equal to 4). The following conditions apply:
    • Participants with clinically mild atopic eczema/atopic dermatitis and clinically mild psoriasis may be included at the Investigator's discretion (e.g., if small amounts of regular topical steroids are used, no eczema in cubital fossa; moderate to large amounts of daily dermal corticosteroids is an exclusion).
    • Rhinitis (including hay fever) which is clinically active or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of IMP dosing. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI’s discretion.
    • Participants with a physician diagnosed underactive thyroid who have been controlled on treatment for at least 6 months with evidence of a normal thyroid function test (TFT) can be included at the discretion of the PI.
    • Any concurrent serious illness including history of malignancy that may interfere with the aims of the study or a subject completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
    • Participants reporting physician diagnosed migraine can be included as long as there are not associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion.
    • Participants with physician diagnosed mild Irritable Bowel Syndrome (IBS) not requiring regular treatment can be included at the discretion of the PI.
    3. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral inoculation, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
    4. Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months prior to IMP dosing and/or history of being hospitalized due to epistaxis on any previous occasion.
    5. History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to IMP dosing.
    6. And/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations.
    7. History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
    8. Confirmed positive test for drugs of abuse prior to randomization.
    9. History or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits), or excessive consumption of xanthine containing substances (e.g. daily intake in excess of 5 cups of caffeinated drinks e.g. coffee, tea, cola).
    10. Is positive for human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test..
    Prior/Concomitant Therapy
    11. Evidence of receipt of vaccine within the 4 weeks prior to IMP dosing.
    12. Intention to receive any vaccine(s) before the last day of Follow-up. (NB. No travel restrictions will apply after the poststudy visit).
    13. Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior IMP dosing or planned during the 3 months after the final visit.
    14. Use within 7 days prior to IMP dosing of any medication or product (prescription or over-the-counter), for symptoms of hay fever, dermatitis, nasal congestion or respiratory tract infections including the use of regular nasal or dermal corticosteroids or antibiotics, apart from those described and allowed in exclusion criteria 2.
    15. Receipt of systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 6 months prior to IMP dosing.
    [Please refer to clinical protocol for a full list of exclusion criteria].
    E.5 End points
    E.5.1Primary end point(s)
    Area Under Viral Load-time Curve (VL-AUC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
    E.5.2Secondary end point(s)
    1. Incidence of Symptomatic RSV Infection
    2. Number of Participants with an Adverse Event (AE)
    3. Number of Participants with a Serious Adverse Event (SAE)
    4. Serum Concentration of MK-1654
    5. Concentration of RSV Serum Neutralizing Antibody Titers
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
    2. Up to 180 days
    3. Up to 180 days
    4. Days 1, 8, 15, 29, 40, and 57
    5. Days 1, 29, 40, and 57
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Antiviral activity
    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. 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 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 No
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state90
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-03
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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