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

    Summary
    EudraCT number
    		 2020-004448-27
    Trial protocol
    		 DE  
    Global end of trial date
    23 Sep 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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Uni-Koeln-4370
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04631705
    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
    19 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    - To evaluate the safety and tolerability of a single inhaled application of DZIF-10c in SARS-CoV-2-uninfected and SARS-CoV-2-infected individuals. - To evaluate the safety and tolerability of a single combined inhaled and intravenous application of DZIF-10c in SARS-CoV-2-infected individuals.
    Protection of trial subjects
    - Frequent safety labs - Safety Monitoring Committee - Hospitalization and monitoring for open-label dose escalation phase
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 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: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    45
    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-1C: Generally healthy volunteers negative for SARS-CoV-2 RNA in swab and negative for SARS-CoV-2 antibodies by serology. Groups 2A-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-1C were open label and sequentially enrolled - Groups 2A-2C were open label and sequentially enrolled - Group 2D was randomised and double blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1A: Healthy, 50 mg inh.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Arm title
    		 1B: Healthy, 100 mg inh.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Arm title
    		 1C: Healthy, 250 mg inh.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Arm title
    		 2A: Infected, 50 mg inh.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Arm title
    		 2B: Infected, 100 mg inh.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Arm title
    		 2C: Infected, 250 mg inh.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Arm title
    		 2D: Infected, placebo inh., placebo i.v.
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Sterile normal saline (0.9% NaCl) used as placebo for infusion

    Investigational medicinal product name
    Diluent solution for DZIF-10c
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Diluent for DZIF-10c used as placebo for nebuliser solution

    Arm title
    		 2D: Infected, 250 mg inh., placebo i.v.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c (inhalation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Sterile normal saline (0.9% NaCl) used as placebo for infusion

    Arm title
    		 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DZIF-10c (inhalation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    DZIF-10c for inhalation in nebuliser solution; see arm title for dosage

    Investigational medicinal product name
    DZIF-10c (infusion)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    DZIF-10c for intravenous infusion; see arm title for dosage

    Number of subjects in period 1
    		1A: Healthy, 50 mg inh. 1B: Healthy, 100 mg inh. 1C: Healthy, 250 mg inh. 2A: Infected, 50 mg inh. 2B: Infected, 100 mg inh. 2C: Infected, 250 mg inh. 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Started
    3
    3
    3
    3
    3
    3
    10
    8
    9
    Completed
    3
    3
    3
    3
    3
    3
    9
    8
    9
    Not completed
    0
    0
    0
    0
    0
    0
    1
    0
    0
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1A: Healthy, 50 mg inh.
    Reporting group description
    		 -

    Reporting group title
    1B: Healthy, 100 mg inh.
    Reporting group description
    		 -

    Reporting group title
    1C: Healthy, 250 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2A: Infected, 50 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2B: Infected, 100 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2C: Infected, 250 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, placebo inh., placebo i.v.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, 250 mg inh., placebo i.v.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Reporting group description
    		 -

    Reporting group values
    		 1A: Healthy, 50 mg inh. 1B: Healthy, 100 mg inh. 1C: Healthy, 250 mg inh. 2A: Infected, 50 mg inh. 2B: Infected, 100 mg inh. 2C: Infected, 250 mg inh. 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v. Total
    Number of subjects
    		 3 3 3 3 3 3 10 8 9 45
    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))
    		 43 (29 to 44) 33 (32 to 44) 27 (20 to 29) 35 (30 to 62) 39 (25 to 42) 41 (32 to 46) 34 (28 to 36) 32 (29 to 46) 28 (27 to 38) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 2 1 2 1 2 2 4 15
        Male
    		 3 2 1 2 1 2 8 6 5 30

    End points

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    End points reporting groups
    Reporting group title
    1A: Healthy, 50 mg inh.
    Reporting group description
    		 -

    Reporting group title
    1B: Healthy, 100 mg inh.
    Reporting group description
    		 -

    Reporting group title
    1C: Healthy, 250 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2A: Infected, 50 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2B: Infected, 100 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2C: Infected, 250 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, placebo inh., placebo i.v.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, 250 mg inh., placebo i.v.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Reporting group description
    		 -

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

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    End point title
    		 Proportion of patients with any AE within 7 d of study drug administration [1]
    End point description
    End point type
    Primary
    End point timeframe
    Over first 7 days after study drug administration
    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, 50 mg inh. 1B: Healthy, 100 mg inh. 1C: Healthy, 250 mg inh. 2A: Infected, 50 mg inh. 2B: Infected, 100 mg inh. 2C: Infected, 250 mg inh. 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    10
    8
    9
    Units: % individuals
        number (not applicable)
    66.7
    33.3
    33.3
    100
    33.3
    0
    60.0
    37.5
    33
    No statistical analyses for this end point

    Secondary: Area under the Curve (AUC) for DZIF-10c serum levels from day 1 to day 29

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    End point title
    		 Area under the Curve (AUC) for DZIF-10c serum levels from day 1 to day 29 [2]
    End point description
    Only for individuals with detectable antibody levels and with n of at least 3 individuals with values enabling analysis
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 29
    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
    		 1C: Healthy, 250 mg inh. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Number of subjects analysed
    3
    4
    9
    Units: µg*h/ml
        geometric mean (geometric coefficient of variation)
    284 ± 18.2
    225 ± 39.2
    174000 ± 14.5
    No statistical analyses for this end point

    Secondary: Individuals developing anti-drug antibodies

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    End point title
    		 Individuals developing anti-drug antibodies [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, 50 mg inh. 1B: Healthy, 100 mg inh. 1C: Healthy, 250 mg inh. 2A: Infected, 50 mg inh. 2B: Infected, 100 mg inh. 2C: Infected, 250 mg inh. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    8
    9
    Units: individuals
    0
    0
    0
    0
    0
    0
    0
    0
    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) [4]
    End point description
    Time-weighted average change
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 29
    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: Only randomized and controlled phase shown; preplanned as hypothesis-generating analysis.
    End point values
    		 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Number of subjects analysed
    10
    8
    9
    Units: Adjusted mean AOC
    number (not applicable)
        Over 7 days
    -1.932
    -2.100
    -1.716
        Over 14 days
    -2.780
    -3.044
    -2.786
        Over 28 days
    -3.616
    -3.652
    -3.652
    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) [5]
    End point description
    Mixed model for repeated measures
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 29
    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: Only randomized and controlled phase shown; preplanned as hypothesis-generating analysis.
    End point values
    		 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Number of subjects analysed
    10
    8
    9
    Units: Adjusted mean
    number (not applicable)
        Over 7 days
    -3.4
    -3.4
    -3.2
        Over 14 days
    -4.4
    -4.1
    -4.4
        Over 28 days
    -4.4
    -4.3
    -4.4
    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, 50 mg inh.
    Reporting group description
    		 -

    Reporting group title
    1B: Healthy, 100 mg inh.
    Reporting group description
    		 -

    Reporting group title
    1C: Healthy, 250 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2A: Infected, 50 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2B: Infected, 100 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2C: Infected, 250 mg inh.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, placebo inh., placebo i.v.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, 250 mg inh., placebo i.v.
    Reporting group description
    		 -

    Reporting group title
    2D: Infected, 250 mg inh., 40 mg/kg i.v.
    Reporting group description
    		 -

    Serious adverse events
    		 1A: Healthy, 50 mg inh. 1B: Healthy, 100 mg inh. 1C: Healthy, 250 mg inh. 2A: Infected, 50 mg inh. 2B: Infected, 100 mg inh. 2C: Infected, 250 mg inh. 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg 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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    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, 50 mg inh. 1B: Healthy, 100 mg inh. 1C: Healthy, 250 mg inh. 2A: Infected, 50 mg inh. 2B: Infected, 100 mg inh. 2C: Infected, 250 mg inh. 2D: Infected, placebo inh., placebo i.v. 2D: Infected, 250 mg inh., placebo i.v. 2D: Infected, 250 mg inh., 40 mg/kg 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%)
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    7 / 10 (70.00%)
    5 / 8 (62.50%)
    4 / 9 (44.44%)
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    0
    0
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    2
    1
    0
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 10 (50.00%)
    2 / 8 (25.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    6
    2
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    0
    Psychiatric disorders
    Aphasia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 10 (20.00%)
    2 / 8 (25.00%)
    3 / 9 (33.33%)
         occurrences all number
    1
    0
    0
    2
    0
    1
    3
    2
    6
    Sciatica
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Parosmia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gonococcal infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2021
    - Reduced frequency of post inhalation pulmonary function testing
    20 Apr 2021
    - 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 and early termination of enrolment.
    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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