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    Clinical Trial Results:
    A single-blind, placebo controlled, randomised study to evaluate antiviral activity and safety and pharmacokinetics of inhaled PC786 against respiratory syncytial virus (RSV) in healthy adult subjects in a virus challenge model

    Summary
    EudraCT number
    		 2017-002563-18
    Trial protocol
    		 GB  
    Global end of trial date
    09 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2019
    First version publication date
    29 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PC_RSV_003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03382431
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pulmocide Ltd
    Sponsor organisation address
    52 Princes Gate, London, United Kingdom, SW7 2PG
    Public contact
    Director of Clinical Development, Pulmocide Ltd, +44 7766250133, Lindsey@pulmocide.com
    Scientific contact
    Director of Clinical Development, Pulmocide Ltd, +44 7766250133, Lindsey@pulmocide.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the antiviral effect of inhaled PC786 compared to placebo in healthy adults who have received a clinical challenge strain of RSV (RSV-A Memphis 37b virus) inoculated via the intranasal route
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements. Known instances of non-conformance were documented and are not considered to have had an impact on the overall conclusions of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Fifty six (56) healthy adult subjects were due to be inoculated with challenge virus and dosed with PC786/placebo to ensure that data for 40 evaluable subjects were obtained. A total of 56 healthy subjects were recruited to take part in the study at a single investigational site in the UK between 14 Nov 2017 and 28 Feb 2018.

    Pre-assignment
    Screening details
    		 A total of 163 subjects were screened to take part in the study; 107 subjects failed screening. Fifty six subjects were enrolled, inoculated with challenge virus and randomised to study treatment. All subjects completed the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PC786
    Arm description
    		 Twice daily doses of PC786 5 mg for a total of 10 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    PC786 powder for reconstitution 30 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    Twice daily doses of PC786 5 mg administered as an inhalation via a facemask for a total of 10 doses

    Arm title
    		 Placebo
    Arm description
    		 Twice daily doses of placebo for a total of 10 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Twice daily doses of placebo administered as an inhalation via a facemask

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to a difference in appearance of the active and placebo treatments, the investigational product was prepared and dosed by independent staff team members who did not undertake any other study duties.
    Number of subjects in period 1
    		PC786 Placebo
    Started
    28
    28
    Completed
    28
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PC786
    Reporting group description
    		 Twice daily doses of PC786 5 mg for a total of 10 doses

    Reporting group title
    Placebo
    Reporting group description
    		 Twice daily doses of placebo for a total of 10 doses

    Reporting group values
    		 PC786 Placebo Total
    Number of subjects
    		 28 28 56
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 28 28 56
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.4 ( 5.63 ) 26.3 ( 5.89 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 9 19
        Male
    		 18 19 37

    End points

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    End points reporting groups
    Reporting group title
    PC786
    Reporting group description
    		 Twice daily doses of PC786 5 mg for a total of 10 doses

    Reporting group title
    Placebo
    Reporting group description
    		 Twice daily doses of placebo for a total of 10 doses

    Primary: Primary efficacy endpoint

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    End point title
    		 Primary efficacy endpoint
    End point description
    The analysis of viral load AUC (time zero to Day 12) by nasal wash RT-qPCR for the ITT-IA analysis set described as all randomised subjects who received the challenge virus and at least one dose of study medication who had a positive quantitative PCR value >1.0 Log PFUe/mL immediately before dosing OR any subject who was qPCR negative before dosing and who subsequently had two or more qPCR positive results ( >1.0 Log PFUe/mL) after the first dose dose of study medication.
    End point type
    Primary
    End point timeframe
    From the last RT-qPCR measurement collected prior to the first dose of IMP until the last RT-qPCR measurement collected to to Day 12
    End point values
    		 PC786 Placebo
    Number of subjects analysed
    19
    15
    Units: log10 PFUe x hr/mL
        least squares mean (standard deviation)
    325.8 ( 199.19 )
    495.5 ( 199.22 )
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    AUC descriptive statistics for derived RSV viral load parameters by treatment group (n, mean, SD, median (quartiles 1 and 3), minimum and maximum and comparison of treatment group means (mean, SE, 95% CI and p-value) were summarised.
    Comparison groups
    PC786 v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 = 0.0209
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - In this post-hoc analysis, an RSV viral load cut-off value of 1.0 Log10 PFUe/mL was used to define a new population, the Intent-to-Treat Infected Alternative (ITT-IA) population. This cut-off was designed to avoid the PCR detection of the inoculum itself in the absence of infection and improved the specificity of the assay to identify subjects truly infected with RSV.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Consent until final follow up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    PC786
    Reporting group description
    		 Twice daily doses of PC786 5 mg for a total of 10 doses

    Reporting group title
    Placebo
    Reporting group description
    		 Twice daily doses of placebo for a total of 10 doses

    Serious adverse events
    		 PC786 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 PC786 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 28 (42.86%)
    14 / 28 (50.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 28 (14.29%)
         occurrences all number
    4
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 28 (14.29%)
         occurrences all number
    5
    4
    Forced expiratory volume decreased
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 28 (7.14%)
         occurrences all number
    3
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Forced vital capacity decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Nasal injury
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 28 (10.71%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Application site rash
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Photophobia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 28 (7.14%)
         occurrences all number
    1
    2
    Cough
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin mass
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Costochondritis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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