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    Summary
    EudraCT Number:2021-003463-97
    Sponsor's Protocol Code Number:RVL-VRL01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-003463-97
    A.3Full title of the trial
    A Phase IIb Study Assessing Prophylactic Efficacy of Intranasal REVTx-99 in an H3N2 Influenza Challenge Model in Healthy Subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Efficacy of REVTx-99 against Influenza infection.
    A.4.1Sponsor's protocol code numberRVL-VRL01
    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 SponsorRevelation Biosciences, 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 supportRevelation Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRevelation Biosciences
    B.5.2Functional name of contact pointRevelation Biosciences Information
    B.5.3 Address:
    B.5.3.1Street Address4660 La Jolla Village Drive, Suite 100
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92122
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650 800 3717
    B.5.5Fax number+1619-393-2225
    B.5.6E-mailinfo@revbiosciences.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 nameREVTx-99
    D.3.4Pharmaceutical form Nasal drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMonophosphoryl Lipid A
    D.3.9.1CAS number 1246298-63-4
    D.3.9.3Other descriptive nameMonophosphoryl Lipid A, PHAD®
    D.3.9.4EV Substance CodeSUB20575
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 placeboNasal drops
    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
    Influenza A
    E.1.1.1Medical condition in easily understood language
    Flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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 efficacy of REVTx-99 in reducing influenza virus load in the upper airways during infection.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of REVTx-99 treatment prophylactically in healthy subjects challenged with Influenza A H3N2 virus.
    To determine the overall effect of REVTx-99 on measurements of influenza disease severity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy males and females aged 18-55 years inclusive at the point of study screening.
    2. Subject must be a non-smoker, non-tobacco user and non-nicotine product user or a former smoker/user (has not smoked, vaped or used tobacco/nicotine products in the 6 months prior to dosing).
    3. Subject must have normal pulmonary function as measured by spirometry defined as 1) a forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio ≥0.70 and 2) FEV1 ≥80 % at screening and 3) peripheral oxygen saturation (SpO2) ≥92% on room air.
    4. Subject must have a Body Mass Index (BMI) of ≥18.0kg/M2 and ≤32.0kg/M2.
    5. Female subjects must be willing not to become pregnant for at least 8 weeks after last dose of study drug, not be breast feeding.
    6. Female subjects must be not pregnant, and one of the following:
    Of non-childbearing potential (i.e. women who have had a hysterectomy bilateral salpingectomy or bilateral oophorectomy or are post-menopausal, as defined by no menses in ≥1 year), Or, Of childbearing potential but agrees to practice highly effective contraception from screening until 8 weeks after the date of Viral Challenge / last dose of IMP (whichever occurs last). Highly effective methods of contraception include one or more of the regimens as outlined in Section 8.5.1 of the protocol.
    7. Male subjects must be surgically sterile or using a medically acceptable contraceptive regimen
    8. Subjects in agreement not to use prescription or over-the-counter medications within 14 days prior to receiving study drug or placebo, through to the final follow-up visit, unless approved by the investigator and sponsor medical monitor.
    9. Sero-suitability for challenge virus MNT≤20.
    10. Negative screen for respiratory pathogens by RT-PCR
    E.4Principal exclusion criteria
    1. Subjects with self-reported of medically documented chronic pulmonary disease (e.g., asthma, COPD).
    2. Subjects with self-reported or medically documented history of nasal or allergic disease (Allergic rhinitis, sinusitis, asthma) requiring regular use of medication. A history of resolved childhood asthma before the age of 12 is acceptable.
    3. Subjects with self-reported or medically documented craniofacial anomalies or temporal facial muscular paralysis (e.g., Bell’s Palsy) or significant abnormality altering the anatomy of the nose or nasopharynx (including significant nasal polyps).
    4. Subjects with significant self-reported or medically documented cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
    5. Subjects with self-reported or medically documented immunosuppression, immunodeficiency, autoimmunity (with the exception of atopic dermatitis/eczema) or ongoing malignancy.
    6. Subjects with a history of malignancy within 3 years prior to screening.
    7. Subjects with self-reported or medically documented neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy (exception for febrile seizure), stroke, seizures).
    8. Subjects with clinically significant abnormal electrocardiogram (ECG) and/or parameters, as determined by the Investigator.
    9. Incidence or clinical evidence of acute respiratory illness in the 28 days prior to study drug administration.
    10. Incidence of a SARS-CoV-2 infection in the past 3 months, defined by a positive test result.
    11. Subjects having undergone nasal or sinus surgery in the 6 months prior to study drug administration.
    12. Subject has had a new nasal piercing of any kind in the last 6 months prior to study drug administration.
    13. Subjects with a history of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
    14. Subjects with any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or history of being hospitalized due to epistaxis on any previous occasion.
    15. Receipt of any intranasal medication or nasal topical treatment in the 28 days prior to study drug administration, or plan to use any nasal products during the study.
    16. Prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months taken from the date of study drug administration.
    17. Subject in receipt of any vaccine in the 14 days prior to study confinement drug administration.

    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve (AUC) of viral load by RT-qPCR from NP swabs
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 1 (pre-virus challenge) to Day 10
    E.5.2Secondary end point(s)
    The safety endpoints of this study are as follows:
    1.Incidence of treatment-emergent AEs (TEAE), severity, seriousness, and causality
    2.Absolute values and change from baseline in routine clinical and laboratory parameters
    3.Treatment- related physical examination findings
    4.Absolute values and change from baseline in peak flow


    The secondary endpoints of this study are as follows:
    1.The Area Under the Curve (AUC) of Total Symptom Score
    2.Duration of symptoms
    3.Peak Symptoms Score
    4.Peak Virus load
    5.Duration of influenza virus presence
    6.Incidence of Mild to Moderate Influenza disease (MMID)
    7.Incidence of seroconversion
    E.5.2.1Timepoint(s) of evaluation of this end point
    The safety endpoints:
    Starting post-dose (Cohort 1)/post-first dose (Cohort 2) to Day 21.

    The secondary endpoints:
    The Area Under the Curve (AUC) of Total Symptom Score, Duration of symptoms, Peak Symptoms Score, Peak Virus load, Duration of influenza virus presence, Incidence of Mild to Moderate Influenza disease (MMID): From Day 1 (pre-virus challenge) to Day 10.
    Incidence of seroconversion: Assess the effect of REVTx-99 on seroconversion measured by the ratio of Influenza A (H3N2 – challenge strain) virus antibodies at Day 10 and Day 21 versus Day 1 (pre-virus challenge), compared to placebo.
    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 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) 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.8.2.4Number 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
    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 months6
    E.8.9.1In the Member State concerned days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    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 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 state60
    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)
    There are no plans for treatment or care after the subject has ended the participation in the trial.
    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 Decision2021-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-06
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