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    Clinical Trial Results:
    Randomized, double-blind, placebo-controlled, single-centre, phase IIa study in healthy volunteers to evaluate the efficacy and safety of CT-P27 in an influenza challenge model

    Summary
    EudraCT number
    		 2013-004544-32
    Trial protocol
    		 GB  
    Global end of trial date
    19 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P27/2.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celltrion, Inc
    Sponsor organisation address
    Academy-ro, Incheon, Korea, Republic of,
    Public contact
    Head of Clinical Planning Department, Celltrion, Inc, +82 8505000, contact@celltrion.com
    Scientific contact
    Head of Clinical Planning Department, Celltrion, Inc, +82 8505000, contact@celltrion.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
    13 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the reduction in AUC of virus load from the nasopharyngeal mucosa as measured by quantitative PCR, in the CT-P27 treatment groups compared to placebo, post Viral Challenge, and post virus shedding.
    Protection of trial subjects
    Every effort was made to monitor the health of the volunteers to minimize the unforeseen and not anticipated risks.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2014
    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: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    81
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in United Kingdom.

    Pre-assignment
    Screening details
    		 Study-specific screening (SSS) occurred from Day -56 to Day -3. Assessments to determine subjects’ eligibility to participate and baseline measurements were performed. First screening visit was on 15 February 2014.

    Period 1
    Period 1 title
    Study specific screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The Investigator and all other clinical and non-clinical staff were remain blinded to the treatment allocation, until after the database has been locked and approval for study unblinding has been given.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P27 10mg/kg
    Arm description
    		 Subjects received 10 mg/kg CT-P27
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P27
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Arm title
    		 CT-P27 20mg/kg
    Arm description
    		 Subjects received 20 mg/kg CT-P27
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P27
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Number of subjects in period 1
    		CT-P27 10mg/kg CT-P27 20mg/kg Placebo
    Started
    27
    27
    27
    Completed
    27
    27
    27
    Period 2
    Period 2 title
    Quarantine and Challenge
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The Investigator and all other clinical and non-clinical staff were remain blinded to the treatment allocation, until after the database has been locked and approval for study unblinding has been given.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P27 10mg/kg
    Arm description
    		 Subjects received 10 mg/kg CT-P27
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P27
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Arm title
    		 CT-P27 20mg/kg
    Arm description
    		 Subjects received 20 mg/kg CT-P27
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P27
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Number of subjects in period 2
    		CT-P27 10mg/kg CT-P27 20mg/kg Placebo
    Started
    27
    27
    27
    Completed
    27
    27
    27
    Period 3
    Period 3 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The Investigator and all other clinical and non-clinical staff were remain blinded to the treatment allocation, until after the database has been locked and approval for study unblinding has been given.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P27 10mg/kg
    Arm description
    		 Subjects received 10 mg/kg CT-P27
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P27
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours

    Arm title
    		 CT-P27 20mg/kg
    Arm description
    		 Subjects received 20 mg/kg CT-P27
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P27
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-dose IV infusion over 1.5 hours.

    Number of subjects in period 3
    		CT-P27 10mg/kg CT-P27 20mg/kg Placebo
    Started
    27
    27
    27
    Completed
    27
    27
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P27 10mg/kg
    Reporting group description
    		 Subjects received 10 mg/kg CT-P27

    Reporting group title
    CT-P27 20mg/kg
    Reporting group description
    		 Subjects received 20 mg/kg CT-P27

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo

    Reporting group values
    		 CT-P27 10mg/kg CT-P27 20mg/kg Placebo Total
    Number of subjects
    		 27 27 27 81
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    ITT population
    Units: years
        median (full range (min-max))
    		 24.0 (20 to 39) 25.0 (19 to 41) 25.0 (18 to 42) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10 12 32
        Male
    		 17 17 15 49
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-treat (ITT) was defined as all subjects randomised to IMP or placebo. The treatment group was defined as the treatment randomised rather than the treatment actually received. All subjects were included as long as they were randomised, even patients who did not receive a treatment. All baseline and demographic summaries were performed on the ITT population.

    Subject analysis set title
    Efficacy Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Efficacy population was defined as all ITT subjects receiving Challenge Virus and IMP or placebo, with subjects having at least one non-missing result among PCR, cell culture and/or seroconversion detection. All efficacy analyses were performed on the efficacy population unless otherwise specified.

    Subject analysis set title
    Infected Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Infected population was defined as all subjects in the Efficacy population providing at least 2 positive nasopharyngeal swabs within 24 h when tested using quantitative PCR assay. The primary endpoint analysis was on the Infected population. All efficacy analyses were performed on the infected population

    Subject analysis set title
    Per-protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population was defined as all subjects in the Efficacy population who had no major protocol deviations and who complete the quarantine period up to the final day of Quarantine. All efficacy analyses, unless otherwise stated, were performed on the PP population unless the PP population was the same as the efficacy population.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population was defined as subjects who received a complete or partial dose of IMP or placebo, with subjects allocated to the treatment group associated with the treatment actually received. Unless otherwise indicated, all safety analyses were performed on the Safety population. Data for any subjects who were randomised but did not receive study drug were presented in subject listings only.

    Subject analysis set title
    Pharmacokinetic Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK population included all subjects who had received at least one dose of CT-P27 with at least one evaluable PK parameter and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured. The PK evaluation was performed on the PK Population.

    Subject analysis sets values
    		 Intention-to-treat Population Efficacy Population Infected Population Per-protocol Population Safety Population Pharmacokinetic Population
    Number of subjects
    81
    81
    61
    81
    81
    81
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    ITT population
    Units: years
        median (full range (min-max))
    25.0 (18 to 42)
    Gender categorical
    Units: Subjects
        Female
    32
        Male
    49

    End points

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    End points reporting groups
    Reporting group title
    CT-P27 10mg/kg
    Reporting group description
    		 Subjects received 10 mg/kg CT-P27

    Reporting group title
    CT-P27 20mg/kg
    Reporting group description
    		 Subjects received 20 mg/kg CT-P27

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo
    Reporting group title
    CT-P27 10mg/kg
    Reporting group description
    		 Subjects received 10 mg/kg CT-P27

    Reporting group title
    CT-P27 20mg/kg
    Reporting group description
    		 Subjects received 20 mg/kg CT-P27

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo
    Reporting group title
    CT-P27 10mg/kg
    Reporting group description
    		 Subjects received 10 mg/kg CT-P27

    Reporting group title
    CT-P27 20mg/kg
    Reporting group description
    		 Subjects received 20 mg/kg CT-P27

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo

    Subject analysis set title
    Intention-to-treat Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-treat (ITT) was defined as all subjects randomised to IMP or placebo. The treatment group was defined as the treatment randomised rather than the treatment actually received. All subjects were included as long as they were randomised, even patients who did not receive a treatment. All baseline and demographic summaries were performed on the ITT population.

    Subject analysis set title
    Efficacy Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Efficacy population was defined as all ITT subjects receiving Challenge Virus and IMP or placebo, with subjects having at least one non-missing result among PCR, cell culture and/or seroconversion detection. All efficacy analyses were performed on the efficacy population unless otherwise specified.

    Subject analysis set title
    Infected Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Infected population was defined as all subjects in the Efficacy population providing at least 2 positive nasopharyngeal swabs within 24 h when tested using quantitative PCR assay. The primary endpoint analysis was on the Infected population. All efficacy analyses were performed on the infected population

    Subject analysis set title
    Per-protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population was defined as all subjects in the Efficacy population who had no major protocol deviations and who complete the quarantine period up to the final day of Quarantine. All efficacy analyses, unless otherwise stated, were performed on the PP population unless the PP population was the same as the efficacy population.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population was defined as subjects who received a complete or partial dose of IMP or placebo, with subjects allocated to the treatment group associated with the treatment actually received. Unless otherwise indicated, all safety analyses were performed on the Safety population. Data for any subjects who were randomised but did not receive study drug were presented in subject listings only.

    Subject analysis set title
    Pharmacokinetic Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK population included all subjects who had received at least one dose of CT-P27 with at least one evaluable PK parameter and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured. The PK evaluation was performed on the PK Population.

    Primary: AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine

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    End point title
    		 AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
    End point description
    Viral load AUC (Day 1 to Day 9) by nasopharyngeal swab quantitative PCR
    End point type
    Primary
    End point timeframe
    Day 1 to Day 9
    End point values
    		 CT-P27 10mg/kg CT-P27 20mg/kg Placebo
    Number of subjects analysed
    20
    20
    21
    Units: Days*Eq log10 TCID50/mL
        arithmetic mean (standard deviation)
    6.474 ± 9.0090
    6.974 ± 9.0817
    11.639 ± 9.7982
    Statistical analysis title
    		 Wilcoxon Rank-Sum p-value (versus placebo)
    Comparison groups
    CT-P27 10mg/kg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.059
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Wilcoxon Rank-Sum p-value (versus placebo)
    Comparison groups
    CT-P27 20mg/kg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.121
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening to End of study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    CT-P27 10mg/kg
    Reporting group description
    		 -

    Reporting group title
    CT-P27 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 CT-P27 10mg/kg CT-P27 20mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CT-P27 10mg/kg CT-P27 20mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 27 (66.67%)
    19 / 27 (70.37%)
    19 / 27 (70.37%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 27 (11.11%)
    2 / 27 (7.41%)
         occurrences all number
    2
    3
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
         occurrences all number
    1
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    7 / 27 (25.93%)
    0 / 27 (0.00%)
         occurrences all number
    0
    7
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 27 (3.70%)
    2 / 27 (7.41%)
         occurrences all number
    1
    1
    2
    Neutrophil count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    0
    Injury, poisoning and procedural complications
    Procedural haemorrhage
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    2
    Nervous system disorders
    headache
         subjects affected / exposed
    7 / 27 (25.93%)
    6 / 27 (22.22%)
    4 / 27 (14.81%)
         occurrences all number
    7
    6
    4
    Dysgeusia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    2
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 27 (7.41%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    0
    1

    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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