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    Clinical Trial Results:
    A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

    Summary
    EudraCT number
    2020-003503-34
    Trial protocol
    DE  
    Global end of trial date
    11 Aug 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Nov 2022
    First version publication date
    05 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-4288
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04631666
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany,
    Public contact
    Florian Klein, Institute of Virology, 49 22147885800,
    Scientific contact
    Florian Klein, Institute of Virology, 49 22147885800,
    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
    08 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of a single intravenous infusion of DZIF-10c in SARS-CoV-2-uninfected and SARS-CoV-2-infected individuals.
    Protection of trial subjects
    - Safety Monitoring Committee - Frequent safety labs - Hospitalization and monitoring for dosing in open-label dose escalation phase
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Groups 1A, 1B, 1C, 1D: Generally healthy volunteers negative for SARS-CoV-2 RNA in swab and negative for SARS-CoV-2 antibodies by serology. Groups 2C and 2D: SARS-CoV-2-infected volunteers positive for SARS-CoV-2 RNA in swab within 3 days of study drug administration, and within 7 days of symptom onset and/or negative SARS-CoV-2 antibody serology

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst, Carer, Assessor
    Blinding implementation details
    - Groups 1A, 1B, 1C, 1D, and 2C were open label and sequentially enrolled - Group 2D was randomised and double blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    1A: Healthy, 2.5 mg/kg
    Arm description
    Open label
    Arm type
    Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    i.v. Infusion - see Arm title for dosage

    Arm title
    1B: Healthy, 10 mg/kg
    Arm description
    Open label
    Arm type
    Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    i.v. Infusion - see Arm title for dosage

    Arm title
    1C: Healthy, 40 mg/kg
    Arm description
    Open label
    Arm type
    Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    i.v. Infusion - see Arm title for dosage

    Arm title
    1D: Healthy, 80 mg/kg
    Arm description
    Open label
    Arm type
    Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    i.v. Infusion - see Arm title for dosage

    Arm title
    2C: Infected, 40 mg/kg
    Arm description
    Open label
    Arm type
    Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    i.v. Infusion - see Arm title for dosage

    Arm title
    2D: Infected, DZIF-10c, 40 mg/kg
    Arm description
    Randomised and double blind
    Arm type
    Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    i.v. Infusion - see Arm title for dosage

    Arm title
    2D: Infected, Placebo i.v.
    Arm description
    Randomised and double-blind
    Arm type
    Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sterile normale saline 0.9% used as placebo

    Number of subjects in period 1
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v.
    Started
    3
    3
    3
    6
    3
    26
    13
    Completed
    3
    3
    3
    6
    3
    26
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1A: Healthy, 2.5 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1B: Healthy, 10 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1C: Healthy, 40 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1D: Healthy, 80 mg/kg
    Reporting group description
    Open label

    Reporting group title
    2C: Infected, 40 mg/kg
    Reporting group description
    Open label

    Reporting group title
    2D: Infected, DZIF-10c, 40 mg/kg
    Reporting group description
    Randomised and double blind

    Reporting group title
    2D: Infected, Placebo i.v.
    Reporting group description
    Randomised and double-blind

    Reporting group values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v. Total
    Number of subjects
    3 3 3 6 3 26 13 57
    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
    Units: years
        median (inter-quartile range (Q1-Q3))
    26 (22 to 34) 28 (27 to 39) 28 (28 to 28) 26.5 (26 to 28) 43 (41 to 48) 40 (30 to 52) 32 (25 to 47) -
    Gender categorical
    Units: Subjects
        Female
    0 3 1 5 2 11 5 27
        Male
    3 0 2 1 1 15 8 30

    End points

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    End points reporting groups
    Reporting group title
    1A: Healthy, 2.5 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1B: Healthy, 10 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1C: Healthy, 40 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1D: Healthy, 80 mg/kg
    Reporting group description
    Open label

    Reporting group title
    2C: Infected, 40 mg/kg
    Reporting group description
    Open label

    Reporting group title
    2D: Infected, DZIF-10c, 40 mg/kg
    Reporting group description
    Randomised and double blind

    Reporting group title
    2D: Infected, Placebo i.v.
    Reporting group description
    Randomised and double-blind

    Primary: Proportion of patients with any AE within 7 d of study drug infusion

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    End point title
    Proportion of patients with any AE within 7 d of study drug infusion [1]
    End point description
    End point type
    Primary
    End point timeframe
    Over first 7 days after trial drug infusion
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v.
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    13
    Units: % individuals
        number (not applicable)
    66.7
    33.3
    0
    0
    0
    42.3
    61.5
    No statistical analyses for this end point

    Secondary: DZIF-10c elimination half life

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    End point title
    DZIF-10c elimination half life [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    Units: days
        geometric mean (geometric coefficient of variation)
    28.4 ± 17.5
    24.2 ± 12.8
    20.1 ± 9.53
    20.9 ± 25.4
    16.8 ± 45
    21.8 ± 12.2
    No statistical analyses for this end point

    Secondary: DZIF-10c peak serum concentration

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    End point title
    DZIF-10c peak serum concentration [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    Units: µg/ml
        geometric mean (geometric coefficient of variation)
    54.3 ± 12.6
    207 ± 8.92
    738 ± 7.94
    1480 ± 10.2
    983 ± 8.9
    970 ± 21.5
    No statistical analyses for this end point

    Secondary: DZIF-10c Area under the Curve

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    End point title
    DZIF-10c Area under the Curve [4]
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    Units: µg h/ml
        geometric mean (geometric coefficient of variation)
    15400 ± 5.79
    61700 ± 14.3
    212000 ± 18.9
    358000 ± 14.0
    236000 ± 24.4
    235000 ± 15.5
    No statistical analyses for this end point

    Secondary: DZIF-10c clearance

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    End point title
    DZIF-10c clearance [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    Units: ml/d
        geometric mean (geometric coefficient of variation)
    311 ± 10.6
    242 ± 26.8
    282 ± 40.8
    341 ± 14.1
    280 ± 24.2
    339 ± 20.6
    No statistical analyses for this end point

    Secondary: DZIF-10c volume of distribution Vz

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    End point title
    DZIF-10c volume of distribution Vz [6]
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    Units: ml
        geometric mean (geometric coefficient of variation)
    12800 ± 11.7
    8460 ± 18.0
    8160 ± 45.7
    10300 ± 21.8
    6790 ± 29.6
    10700 ± 19.7
    No statistical analyses for this end point

    Secondary: Anti-Drug Antibody Development

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    End point title
    Anti-Drug Antibody Development [7]
    End point description
    Individuals developing anti-drug antibodies
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg
    Number of subjects analysed
    3
    3
    3
    6
    3
    26
    Units: individuals
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Anti-Drug Antibody Peak Titer

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    End point title
    Anti-Drug Antibody Peak Titer [8]
    End point description
    Peak serum anti-drug antibody titer in individuals developing anti-drug antibodies
    End point type
    Secondary
    End point timeframe
    Study period
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive end point
    End point values
    2C: Infected, 40 mg/kg
    Number of subjects analysed
    1
    Units: Reciprocal serum titer
        number (not applicable)
    960
    No statistical analyses for this end point

    Secondary: SARS-CoV-2 viral load absolute change from baseline (NP swabs, E gene, time-weighted average change)

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    End point title
    SARS-CoV-2 viral load absolute change from baseline (NP swabs, E gene, time-weighted average change) [9]
    End point description
    Time-weighted average change
    End point type
    Secondary
    End point timeframe
    Up to day 28 visit
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only randomized and controlled phase shown; preplanned as hypothesis-generating analysis
    End point values
    2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v.
    Number of subjects analysed
    26
    13
    Units: Adjusted mean AOC
    number (not applicable)
        Over 7 days
    -2.035
    -1.449
        Over 14 days
    -3.273
    -2.668
        Over 28 days
    -3.938
    -3.576
    No statistical analyses for this end point

    Secondary: SARS-CoV-2 viral load absolute change from baseline (NP swabs, E gene, MMRM)

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    End point title
    SARS-CoV-2 viral load absolute change from baseline (NP swabs, E gene, MMRM) [10]
    End point description
    Mixed model for repeated measures
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 29
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only randomized and controlled phase shown; preplanned as hypothesis-generating analysis
    End point values
    2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v.
    Number of subjects analysed
    26
    13
    Units: Adjusted mean
    number (not applicable)
        Over 7 days
    -4.3
    -3.3
        Over 14 days
    -4.5
    -4.3
        Over 28 days
    -4.7
    -4.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events: All adverse events after drug intake until final study visit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    1A: Healthy, 2.5 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1B: Healthy, 10 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1C: Healthy, 40 mg/kg
    Reporting group description
    Open label

    Reporting group title
    1D: Healthy, 80 mg/kg
    Reporting group description
    Open label

    Reporting group title
    2C: Infected, 40 mg/kg
    Reporting group description
    Open label

    Reporting group title
    2D: Infected, DZIF-10c, 40 mg/kg
    Reporting group description
    Randomised and double blind

    Reporting group title
    2D: Infected, Placebo i.v.
    Reporting group description
    Randomised and double-blind

    Serious adverse events
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    1A: Healthy, 2.5 mg/kg 1B: Healthy, 10 mg/kg 1C: Healthy, 40 mg/kg 1D: Healthy, 80 mg/kg 2C: Infected, 40 mg/kg 2D: Infected, DZIF-10c, 40 mg/kg 2D: Infected, Placebo i.v.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    18 / 26 (69.23%)
    10 / 13 (76.92%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    8 / 26 (30.77%)
    5 / 13 (38.46%)
         occurrences all number
    0
    0
    1
    0
    0
    9
    5
    Hyposmia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 26 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Disturbance in attention
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Hypogeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Parosmia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Ageusia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    4 / 26 (15.38%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    2
    Chest discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    3 / 26 (11.54%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    1
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    8 / 26 (30.77%)
    4 / 13 (30.77%)
         occurrences all number
    0
    0
    0
    0
    0
    10
    5
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    4 / 26 (15.38%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2021
    Addition of higher dose open label group and changes in description of study drug administration procedure

    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.
    Limited sample size.
    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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