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    Clinical Trial Results:
    A Phase 2A, Randomized, Double-Blind, Placebo- Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction

    Summary
    EudraCT number
    		 2017-000047-41
    Trial protocol
    		 GB   HU   PL  
    Global end of trial date
    02 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FDY-5301-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03470441
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Faraday Pharmaceuticals, Inc.
    Sponsor organisation address
    1616 Eastlake Ave E, Suite 560, Seattle, United States, 98102
    Public contact
    Simon Tulloch, Faraday Pharmaceuticals Inc., +1 206-492-5310, trandall@FaradayPharma.com
    Scientific contact
    Simon Tulloch, Faraday Pharmaceuticals Inc., +1 206-492-5310, trandall@FaradayPharma.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
    01 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety, efficacy and pharmacokinetics (PK) of 3 dose levels of FDY-5301 compared to placebo in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
    Protection of trial subjects
    This trial complied with the International Conference on Harmonization Tripartite Guideline on Good Clinical Practice, the ethical principles stated in the latest version of the Declaration of Helsinki, and the applicable local and international regulations, whichever provide the greater protection of the individual.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    United Kingdom: 64
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    120
    EEA total number of subjects
    50
    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)
    71
    From 65 to 84 years
    49
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first participant enrolled on October 27, 2017 in study centers in Poland, Hungary, UK, and the United States.

    Pre-assignment
    Screening details
    		 A total of 120 subjects were randomized 3:1 to receive one of three dosage amounts of study drug or placebo.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental FDY-5301 Low Dose
    Arm description
    		 0.5 mg/kg FDY-5301
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium Iodide
    Investigational medicinal product code
    FDY-5301
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    FDY-5301 0.5 mg/kg will be administered intravenously (IV) by bolus injection between an hour and 5 minutes prior to coronary artery reperfusion.

    Arm title
    		 Experimental FDY-5301 Intermediate Dose
    Arm description
    		 1.0 mg/kg FDY-5301
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium Iodide
    Investigational medicinal product code
    FDY-5301
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    FDY-5301 1.0 mg/kg will be administered intravenously (IV) by bolus injection between an hour and 5 minutes prior to coronary artery reperfusion.

    Arm title
    		 Experimental FDY-5301 High Dose
    Arm description
    		 2.0 mg/kg FDY-5301
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium Iodide
    Investigational medicinal product code
    FDY-5301
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    FDY-5301 2.0 mg/kg will be administered intravenously (IV) by bolus injection between an hour and 5 minutes prior to coronary artery reperfusion.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Placebo will be administered intravenously (IV) by bolus injection between an hour and 5 minutes prior to coronary artery reperfusion.

    Number of subjects in period 1
    		Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Started
    29
    31
    31
    29
    Completed
    28
    26
    29
    25
    Not completed
    1
    5
    2
    4
         Adverse event, serious fatal
    -
    -
    -
    1
         Consent withdrawn by subject
    1
    4
    1
    3
         Death
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental FDY-5301 Low Dose
    Reporting group description
    		 0.5 mg/kg FDY-5301

    Reporting group title
    Experimental FDY-5301 Intermediate Dose
    Reporting group description
    		 1.0 mg/kg FDY-5301

    Reporting group title
    Experimental FDY-5301 High Dose
    Reporting group description
    		 2.0 mg/kg FDY-5301

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo Total
    Number of subjects
    		 29 31 31 29 120
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 14 22 17 18 71
        From 65-84 years
    		 15 9 14 11 49
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 11 11 10 37
        Male
    		 24 20 20 19 83
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 1 1 3
        Not Hispanic or Latino
    		 29 30 30 28 117
    Race
    Units: Subjects
        White
    		 29 27 30 27 113
        Black
    		 0 1 0 0 1
        Asian
    		 0 1 0 1 2
        American Indian
    		 0 1 0 0 1
        Other
    		 0 1 1 1 3
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 81.62 ± 14.703 81.76 ± 13.453 81.52 ± 15.749 82.23 ± 15.162 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 173 ± 7.8 171 ± 8.2 170 ± 10.7 170 ± 8.3 -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.1 ± 4.17 28 ± 4.29 28.1 ± 4.88 28.5 ± 4.43 -

    End points

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    End points reporting groups
    Reporting group title
    Experimental FDY-5301 Low Dose
    Reporting group description
    		 0.5 mg/kg FDY-5301

    Reporting group title
    Experimental FDY-5301 Intermediate Dose
    Reporting group description
    		 1.0 mg/kg FDY-5301

    Reporting group title
    Experimental FDY-5301 High Dose
    Reporting group description
    		 2.0 mg/kg FDY-5301

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Arrhythmias of Interest, 48 Hours (Overall)

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    End point title
    		 Arrhythmias of Interest, 48 Hours (Overall) [1]
    End point description
    Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
    End point type
    Primary
    End point timeframe
    First 48 hours post-treatment
    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: As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoint was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301’s effect on arrhythmias.
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    28
    29
    29
    26
    Units: Number of Subjects
        Ventricular Fibrillation
    0
    0
    0
    0
        Sustained Ventricular Tachycardia
    0
    0
    0
    0
        Non-Sustained Ventricular Tachycardia
    1
    1
    7
    2
        High-Degree AV Block
    0
    0
    2
    0
        Atrial Fibrillation
    0
    2
    1
    1
    No statistical analyses for this end point

    Primary: Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)

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    End point title
    		 Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) [2]
    End point description
    Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
    End point type
    Primary
    End point timeframe
    48 hours post-treatment
    Notes
    [2] - 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: As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoint was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301’s effect on arrhythmias.
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    28
    29
    29
    26
    Units: Incidence Rate
    number (not applicable)
        Ventricular Fibrillation
    0
    0
    0
    0
        Sustained Ventricular Tachycardia
    0
    0
    0
    0
        Non-Sustained Ventricular Tachycardia
    .0766
    .0797
    .548
    .168
        High-Degree AV Block
    0
    0
    0.157
    0
        Atrial Fibrillation
    0
    .159
    .0783
    .0838
    No statistical analyses for this end point

    Primary: Arrhythmias of Interest, 14 Days (Overall)

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    End point title
    		 Arrhythmias of Interest, 14 Days (Overall) [3]
    End point description
    Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment
    End point type
    Primary
    End point timeframe
    48 hours to 14 days post-treatment
    Notes
    [3] - 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: As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoint was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301’s effect on arrhythmias.
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    28
    28
    28
    25
    Units: Number of subjects
        Ventricular Fibrillation
    0
    0
    0
    0
        Sustained Ventricular Tachycardia
    0
    0
    0
    0
        Non-Sustained Ventricular Tachycardia
    0
    1
    0
    0
        High-Degree AV Block
    0
    0
    2
    0
        Atrial Fibrillation
    3
    2
    2
    1
    No statistical analyses for this end point

    Primary: Arrhythmias of Interest Incidence Rate, 14 Days (Overall)

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    End point title
    		 Arrhythmias of Interest Incidence Rate, 14 Days (Overall) [4]
    End point description
    Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
    End point type
    Primary
    End point timeframe
    48 hours to 14 days post-treatment
    Notes
    [4] - 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: As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoint was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301’s effect on arrhythmias.
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    28
    28
    28
    25
    Units: Incidence rate
    number (not applicable)
        Ventricular Fibrillation
    0
    0
    0
    0
        Sustained Ventricular Tachycardia
    0
    0
    0
    0
        Non-Sustained Ventricular Tachycardia
    0
    0.0147
    0
    0
        High-Degree AV Block
    0
    0
    0.0295
    0
        Atrial Fibrillation
    0.0475
    0.0293
    0.0295
    0.0166
    No statistical analyses for this end point

    Secondary: Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)

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    End point title
    		 Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
    End point description
    Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
    End point type
    Secondary
    End point timeframe
    72 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    22
    18
    20
    20
    Units: INF/VV (%)
        median (full range (min-max))
    19.1 (0 to 50.2)
    16.9 (0 to 51.3)
    19.6 (5.2 to 51.4)
    20.4 (0 to 60.3)
    No statistical analyses for this end point

    Secondary: Infarct Size Relative to Ventricular Volume, 3 Months (Overall)

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    End point title
    		 Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
    End point description
    Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment
    End point type
    Secondary
    End point timeframe
    3 months post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    24
    14
    22
    15
    Units: INF/VV (%)
        median (full range (min-max))
    11.7 (0 to 52)
    11.4 (0 to 50.7)
    8.5 (0 to 49.5)
    14.9 (0 to 48.4)
    No statistical analyses for this end point

    Secondary: Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)

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    End point title
    		 Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
    End point description
    Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
    End point type
    Secondary
    End point timeframe
    72 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    9
    6
    7
    7
    Units: INF/VV (%)
        median (full range (min-max))
    33 (0 to 39.9)
    15.8 (0 to 51.3)
    12.1 (9.8 to 45.8)
    26.7 (0 to 60.3)
    No statistical analyses for this end point

    Secondary: Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)

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    End point title
    		 Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
    End point description
    Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment
    End point type
    Secondary
    End point timeframe
    3 months post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    11
    6
    7
    6
    Units: INF/VV (%)
        median (full range (min-max))
    19.7 (0 to 52)
    10.4 (0 to 50.7)
    9.3 (0 to 34.4)
    22.8 (1.4 to 48.4)
    No statistical analyses for this end point

    Secondary: Left Ventricular End Systolic Volume Index, 72 Hours (Overall)

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    End point title
    		 Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
    End point description
    Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
    End point type
    Secondary
    End point timeframe
    72 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    25
    21
    21
    21
    Units: mL/kg/M2
        median (full range (min-max))
    40 (20 to 65.2)
    32 (15 to 72)
    32 (12 to 68)
    38 (18 to 53)
    No statistical analyses for this end point

    Secondary: Left Ventricular End Systolic Volume Index, 3 Months (Overall)

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    End point title
    		 Left Ventricular End Systolic Volume Index, 3 Months (Overall)
    End point description
    Left ventricular end systolic volume index (LVESVi) at 3 months post-treatment
    End point type
    Secondary
    End point timeframe
    3 months post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    24
    16
    23
    17
    Units: mL/kg/M2
        median (full range (min-max))
    29 (15 to 78)
    25.5 (7 to 100)
    27 (10 to 73)
    36 (14 to 67)
    No statistical analyses for this end point

    Secondary: Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)

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    End point title
    		 Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
    End point description
    Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
    End point type
    Secondary
    End point timeframe
    72 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    10
    7
    8
    7
    Units: mL/kg/M2
        median (full range (min-max))
    45.5 (21 to 65.2)
    32 (15 to 48)
    31 (13.1 to 41)
    42 (18 to 53)
    No statistical analyses for this end point

    Secondary: Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)

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    End point title
    		 Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
    End point description
    Left ventricular end systolic volume index (LVESVi) at 3 months post-treatment
    End point type
    Secondary
    End point timeframe
    3 months post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    11
    6
    8
    7
    Units: mL/kg/M2
        median (full range (min-max))
    37 (16 to 68)
    28 (7 to 43)
    23.5 (14 to 40)
    36 (19 to 67)
    No statistical analyses for this end point

    Secondary: Left Ventricular Ejection Fraction, 72 Hours (Overall)

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    End point title
    		 Left Ventricular Ejection Fraction, 72 Hours (Overall)
    End point description
    Left ventricular ejection fraction at 72 hours post-treatment
    End point type
    Secondary
    End point timeframe
    72 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    25
    21
    21
    21
    Units: mL/kg/M2
        median (full range (min-max))
    51.4 (31.2 to 69.5)
    51.7 (33.8 to 78.6)
    54.5 (35.9 to 75.1)
    48.7 (35.2 to 73.5)
    No statistical analyses for this end point

    Secondary: Left Ventricular Ejection Fraction, 3 Months (Overall)

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    End point title
    		 Left Ventricular Ejection Fraction, 3 Months (Overall)
    End point description
    Left ventricular ejection fraction at 3 months post-treatment
    End point type
    Secondary
    End point timeframe
    3 months post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    24
    16
    23
    17
    Units: mL/kg/M2
        median (full range (min-max))
    59.5 (29 to 72.4)
    58.9 (25 to 87.5)
    63.2 (36.8 to 72.1)
    53.9 (39.1 to 76.9)
    No statistical analyses for this end point

    Secondary: Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)

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    End point title
    		 Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
    End point description
    Left ventricular ejection fraction at 72 hours post-treatment
    End point type
    Secondary
    End point timeframe
    72 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    10
    7
    8
    7
    Units: mL/kg/M2
        median (full range (min-max))
    48 (34.4 to 69.5)
    51.7 (33.8 to 78.6)
    57.3 (35.9 to 75.1)
    43.2 (35.2 to 73.5)
    No statistical analyses for this end point

    Secondary: Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)

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    End point title
    		 Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
    End point description
    Left ventricular ejection fraction at 3 months post-treatment
    End point type
    Secondary
    End point timeframe
    3 months post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    11
    6
    8
    7
    Units: mL/kg/M2
        median (full range (min-max))
    55.7 (34.9 to 72.4)
    57.2 (45.2 to 87.5)
    67.6 (48 to 72.1)
    50.4 (41.2 to 76.9)
    No statistical analyses for this end point

    Secondary: Serum Troponin Concentrations, 48 Hours (Overall)

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    End point title
    		 Serum Troponin Concentrations, 48 Hours (Overall)
    End point description
    Concentration of serum troponins measured over 48 hours post-treatment
    End point type
    Secondary
    End point timeframe
    48 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    25
    25
    24
    19
    Units: AUC4-48 µg/L
        median (full range (min-max))
    90.5 (-19.3 to 383)
    98.1 (0.0274 to 538)
    108 (32.8 to 591)
    112 (4.5 to 752)
    No statistical analyses for this end point

    Secondary: Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)

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    End point title
    		 Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
    End point description
    Concentration of serum troponins measured over 48 hours post-treatment
    End point type
    Secondary
    End point timeframe
    48 hours post-treatment
    End point values
    		 Experimental FDY-5301 Low Dose Experimental FDY-5301 Intermediate Dose Experimental FDY-5301 High Dose Placebo
    Number of subjects analysed
    12
    9
    9
    8
    Units: AUC4-48 µg/L
        median (full range (min-max))
    123 (-19.3 to 3361)
    55 (0.0274 to 538)
    111 (32.8 to 591)
    83.8 (42.5 to 752)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to 3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Experimental FDY-5301 0.5 mg/kg
    Reporting group description
    		 0.5 mg/kg FDY-5301

    Reporting group title
    Experimental FDY-5301 1.0 mg/kg
    Reporting group description
    		 1.0 mg/kg FDY-5301

    Reporting group title
    Experimental FDY-5301 2.0 mg/kg
    Reporting group description
    		 2.0 mg/kg FDY-5301

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Experimental FDY-5301 0.5 mg/kg Experimental FDY-5301 1.0 mg/kg Experimental FDY-5301 2.0 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 29 (24.14%)
    7 / 31 (22.58%)
    4 / 31 (12.90%)
    8 / 29 (27.59%)
         number of deaths (all causes)
    0
    1
    1
    1
         number of deaths resulting from adverse events
    0
    1
    1
    1
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental FDY-5301 0.5 mg/kg Experimental FDY-5301 1.0 mg/kg Experimental FDY-5301 2.0 mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 29 (31.03%)
    4 / 31 (12.90%)
    9 / 31 (29.03%)
    18 / 29 (62.07%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    3 / 31 (9.68%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    3
    1
    Cardiac failure
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    0
    2
    Headache
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    0
    0
    3
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    4 / 31 (12.90%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    4
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    1
    0
    0
    3
    Constipation
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2016
    UK Protocol Version 2.1
    21 Aug 2017
    Poland/Hungary Protocol Version 2
    17 Sep 2017
    US Protocol Version 1
    21 May 2018
    UK Protocol Amendment Version 2.2, Poland/Hungary Protocol Version 3, US Protocol Version 2

    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
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