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    Clinical Trial Results:
    A Phase-2 open label study to assess the pharmacodynamic and pharmacokinetic properties of a single subcutaneous injection of RUC-4 in patients with ST-elevation myocardial infarction presenting to cardiac catheterization lab with planned primary coronary angioplasty

    Summary
    EudraCT number
    		 2019-004282-41
    Trial protocol
    		 NL  
    Global end of trial date
    04 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2022
    First version publication date
    29 Mar 2022
    Other versions
    Summary report(s)
    		 CEL-02 Summary Results 28May2021

    Trial information

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    Trial identification
    Sponsor protocol code
    CEL-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04284995
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CeleCor Therapeutics, Inc.
    Sponsor organisation address
    1155 Camino Del Mar Suite 481, Del Mar, United States, CA 92014
    Public contact
    S. Postma, Diagram BV, 0031 38426 2999, s.postma@diagram-zwolle.nl
    Scientific contact
    S. Postma, Diagram BV, 0031 38426 2999, s.postma@diagram-zwolle.nl
    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
    28 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To assess the PD properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the CCL with the aim to perform primary coronary angioplasty. - To assess the PK properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the CCL with the aim to perform primary coronary angioplasty. - To assess safety and tolerability of RUC-4
    Protection of trial subjects
    At the end of each cohort, the SRC (Safety Review Committee) has received an interim analysis of the safety, laboratory, and PK/PD data. After reviewing the interim analysis, the SRC has provided written recommendation to the PI whether to proceed with the same dose, or escalate to a higher dose or lower the dose to be studied in the next cohort.
    Background therapy
    		 The use of aspirin or an oral P2Y12 antagonist before catheterization is allowed, but not mandated. Heparin is also allowed, as these medications are standard of care for STEMI patients. If heparin was administered pre-hospital, an activated clotting time (ACT) measurement should be performed at the CCL. If the ACT is <200 seconds, additional heparin is recommended. There are no particular prohibitions and restrictions in this study. Regular standard of care is performed from the provision of informed consent through the last study mandated patient visit.
    Evidence for comparator
    		 N/A; no comparatror used in this trial.
    Actual start date of recruitment
    03 Jun 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
    Netherlands: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    16
    From 65 to 84 years
    10
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in subjects with documented STEMI with onset of the cardiac ischemic symptoms within 6 hr before enrollment who are planned for primary PCI. Evaluation for eligibility performed in the CCL and witnessed verbal ICF was obtained. Before hospital discharge written ICF was obtained

    Pre-assignment
    Screening details
    		 Screening period: 03Jun - 07Oct2020. 73 patients screened, 27 patients enrolled. Main reasons not enrolled: - Eligibility criteria not met (20) - Patient admitted outside business hours (14)

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 All patients received a single SC dose of RUC-4 of 0.075 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RUC-4
    Investigational medicinal product code
    140962
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of RUC-4 of 0.075 mg/kg.

    Arm title
    		 Cohort 2
    Arm description
    		 All patients received a single SC dose of RUC-4 of 0.090 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RUC-4
    Investigational medicinal product code
    140962
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of RUC-4 of 0.090 mg/kg.

    Arm title
    		 Cohort 3
    Arm description
    		 All patients received a single SC dose of RUC-4 of 0.110 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RUC-4
    Investigational medicinal product code
    140962
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of RUC-4 of 0.110 mg/kg.

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3
    Started
    8
    9
    10
    Completed
    8
    9
    9
    Not completed
    0
    0
    1
         Consent withdrawn by subject
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.075 mg/kg.

    Reporting group title
    Cohort 2
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.090 mg/kg.

    Reporting group title
    Cohort 3
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.110 mg/kg.

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 Total
    Number of subjects
    		 8 9 10 27
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 6 5 16
        From 65-84 years
    		 3 2 5 10
        85 years and over
    		 0 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59 ± 12.51 63 ± 13.84 62.60 ± 13.09 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 3 7
        Male
    		 6 7 7 20
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population included all enrolled subjects who received a SC dose of RUC-4.

    Subject analysis set title
    PK Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The PK Analysis Set included all subjects who receive a SC dose of RUC-4 and who had evaluable PK data.

    Subject analysis set title
    PD Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The PD Analysis Set included all subjects who receive a SC dose of RUC-4 and who had evaluable PD data.

    Subject analysis sets values
    		 Safety Population PK Population PD Population
    Number of subjects
    27
    26
    24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    16
    15
    14
        From 65-84 years
    10
    10
    9
        85 years and over
    1
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.67 ± 12.79
    62.07 ± 12.86
    61.79 ± 13.36
    Gender categorical
    Units: Subjects
        Female
    7
    7
    6
        Male
    20
    19
    18

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.075 mg/kg.

    Reporting group title
    Cohort 2
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.090 mg/kg.

    Reporting group title
    Cohort 3
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.110 mg/kg.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population included all enrolled subjects who received a SC dose of RUC-4.

    Subject analysis set title
    PK Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The PK Analysis Set included all subjects who receive a SC dose of RUC-4 and who had evaluable PK data.

    Subject analysis set title
    PD Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The PD Analysis Set included all subjects who receive a SC dose of RUC-4 and who had evaluable PD data.

    Primary: Inhibition of TRAP-induced platelet aggregation 15 min post dose

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    End point title
    		 Inhibition of TRAP-induced platelet aggregation 15 min post dose [1]
    End point description
    End point type
    Primary
    End point timeframe
    At 15 minutes after administration of RUC-4
    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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: percent
        arithmetic mean (standard deviation)
    77.48 ± 9.06
    87.46 ± 6.52
    91.70 ± 7.66
    85.54 ± 9.64
    No statistical analyses for this end point

    Primary: Pharmacokinetic Parameter area under the curve from time zero to time of last quantifiable concentration [AUC0-last]

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    End point title
    		 Pharmacokinetic Parameter area under the curve from time zero to time of last quantifiable concentration [AUC0-last] [2]
    End point description
    End point type
    Primary
    End point timeframe
    PK parameters will be determined from blood concentrations at baseline (before study drug administration), 15, 45, 90, 120 and 180 minutes after administration of a single SC injection of RUC-4
    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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PK Population
    Number of subjects analysed
    8
    9
    9
    26
    Units: h*ng/ml
        geometric mean (geometric coefficient of variation)
    93.39 ± 25.61
    126.20 ± 66.12
    117.74 ± 29.37
    112.30 ± 43.99
    No statistical analyses for this end point

    Primary: Inhibition of TRAP-induced platelet aggregation 120 min post dose

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    End point title
    		 Inhibition of TRAP-induced platelet aggregation 120 min post dose [3]
    End point description
    End point type
    Primary
    End point timeframe
    120 minutes post dose
    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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: percent
        arithmetic mean (standard deviation)
    33.59 ± 8.33
    44.46 ± 30.85
    46.18 ± 7.52
    41.41 ± 18.99
    No statistical analyses for this end point

    Primary: Pharmacokinetic Parameter Observed maximum blood concentration (Cmax)

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    End point title
    		 Pharmacokinetic Parameter Observed maximum blood concentration (Cmax) [4]
    End point description
    End point type
    Primary
    End point timeframe
    PK parameters will be determined from blood concentrations at baseline (before study drug administration), 15, 45, 90, 120 and 180 minutes after administration of a single SC injection of RUC-4
    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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PK Population
    Number of subjects analysed
    8
    9
    9
    26
    Units: ng/ml
        geometric mean (geometric coefficient of variation)
    93.63 ± 27.70
    131.04 ± 55.30
    133.02 ± 21.24
    118.78 ± 39.70
    No statistical analyses for this end point

    Primary: Pharmacokinetic Parameter area under the curve from time zero extrapolated to infinite time[AUC0-inf]

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    End point title
    		 Pharmacokinetic Parameter area under the curve from time zero extrapolated to infinite time[AUC0-inf] [5]
    End point description
    End point type
    Primary
    End point timeframe
    PK parameters will be determined from blood concentrations at baseline (before study drug administration), 15, 45, 90, 120 and 180 minutes after administration of a single SC injection of RUC-4
    Notes
    [5] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PK Population
    Number of subjects analysed
    8
    9
    9
    26
    Units: h*ng/mL
        geometric mean (geometric coefficient of variation)
    106.27 ± 20.67
    136.85 ± 61.77
    139.28 ± 31.51
    127.38 ± 41.75
    No statistical analyses for this end point

    Primary: Pharmacokinetic Parameter Observed last blood concentration (Clast)

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    End point title
    		 Pharmacokinetic Parameter Observed last blood concentration (Clast) [6]
    End point description
    End point type
    Primary
    End point timeframe
    PK parameters will be determined from blood concentrations at baseline (before study drug administration), 15, 45, 90, 120 and 180 minutes after administration of a single SC injection of RUC-4
    Notes
    [6] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PK Population
    Number of subjects analysed
    8
    9
    9
    26
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    8.09 ± 31.70
    9.28 ± 22.88
    11.12 ± 42.75
    9.47 ± 34.78
    No statistical analyses for this end point

    Primary: Inhibition of TRAP + PAR-4 induced platelet aggregation 15 min post dose

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    End point title
    		 Inhibition of TRAP + PAR-4 induced platelet aggregation 15 min post dose [7]
    End point description
    End point type
    Primary
    End point timeframe
    At 15 minutes after administration of RUC-4
    Notes
    [7] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: percentage
        arithmetic mean (standard deviation)
    86.03 ± 8.07
    92.75 ± 3.71
    93.04 ± 5.28
    90.61 ± 6.59
    No statistical analyses for this end point

    Primary: Inhibition of TRAP + PAR-4 induced platelet aggregation 120 min post dose

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    End point title
    		 Inhibition of TRAP + PAR-4 induced platelet aggregation 120 min post dose [8]
    End point description
    End point type
    Primary
    End point timeframe
    At 120 minutes after administration of RUC-4
    Notes
    [8] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    8
    Units: percentage
        arithmetic mean (standard deviation)
    20.43 ± 16.38
    33.61 ± 37.43
    34.10 ± 16.23
    29.38 ± 25.10
    No statistical analyses for this end point

    Primary: Proportion of subjects that showed persistence, >= 50% inhibition TRAP induced platelet aggregation

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    End point title
    		 Proportion of subjects that showed persistence, >= 50% inhibition TRAP induced platelet aggregation [9]
    End point description
    End point type
    Primary
    End point timeframe
    120 minutes post dose
    Notes
    [9] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: number
        >= 50%
    0
    2
    4
    6
    No statistical analyses for this end point

    Primary: Proportion of subjects that showed persistence, >= 50% inhibition TRAP + PAR-4 induced platelet aggregation

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    End point title
    		 Proportion of subjects that showed persistence, >= 50% inhibition TRAP + PAR-4 induced platelet aggregation [10]
    End point description
    End point type
    Primary
    End point timeframe
    120 minutes post dose
    Notes
    [10] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: number
        >= 50%
    0
    2
    1
    3
    No statistical analyses for this end point

    Primary: Proportion of subjects that showed >= 77% inhibition TRAP induced platelet aggregation

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    End point title
    		 Proportion of subjects that showed >= 77% inhibition TRAP induced platelet aggregation [11]
    End point description
    End point type
    Primary
    End point timeframe
    15 minutes post dose
    Notes
    [11] - 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: No statistical analysis was performed for this endpoint. All statistical summaries were descriptive in nature. No hypothesis testing was planned for primary and secondary analyses.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: number
        >= 77%
    3
    7
    7
    17
    No statistical analyses for this end point

    Primary: Proportion of subjects that showed >= 77% inhibition TRAP + PAR-4 induced platelet aggregation

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    End point title
    		 Proportion of subjects that showed >= 77% inhibition TRAP + PAR-4 induced platelet aggregation [12]
    End point description
    End point type
    Primary
    End point timeframe
    15 minutes post dose
    Notes
    [12] - 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: No statistical analysis was performed for this endpoint
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 PD Population
    Number of subjects analysed
    8
    8
    8
    24
    Units: number
        >= 77%
    7
    8
    8
    23
    No statistical analyses for this end point

    Other pre-specified: Injection Site Reaction

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    End point title
    		 Injection Site Reaction
    End point description
    Safety and tolerability parameters.
    End point type
    Other pre-specified
    End point timeframe
    At baseline, hospital discharge, 15 days Follow-UP and 30 days Follow-Up.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Safety Population
    Number of subjects analysed
    8
    9
    10
    27
    Units: number
    0
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected beginning after witnessed verbal IC is obtained till end of study, i.e. 30 days after study treatment.
    Adverse event reporting additional description
    All (S)AEs reported spontaneously by the patient or observed by the investigator or his staff were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.075 mg/kg.

    Reporting group title
    Cohort 2
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.090 mg/kg.

    Reporting group title
    Cohort 3
    Reporting group description
    		 All patients received a single SC dose of RUC-4 of 0.110 mg/kg.

    Serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 9 (22.22%)
    4 / 10 (40.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Vascular access site haematoma
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    7 / 9 (77.78%)
    8 / 10 (80.00%)
    Injury, poisoning and procedural complications
    Vascular access site complication
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 9 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    1
    1
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    1
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    3 / 8 (37.50%)
    4 / 9 (44.44%)
    4 / 10 (40.00%)
         occurrences all number
    1
    1
    1
    Fatigue
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    2
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2020
    - Additional PD measurement at 240 minutes if the dose of the study drug is increased (cohort 2 and/or 3) - Add exclusion criteria regarding COVID-19 infection - Definition of causal relationships with study drug and PCI procedure has been added - As the impact of STEMI on RUC-4 PK and PD in patients is not known, study CEL-02 is designed to assess PD and PK properties of the weight-adjusted dose of RUC-4 (mg/kg) required to achieve 77% or greater inhibition of TRAP-induced platelet aggregation (amendment: 77% instead of 90%).
    10 Sep 2020
    -Additional heparin administration if ACT is <200 seconds instead of <250 seconds. The ACT cutoff value for administration of an additional dose of heparin is lowered to <200 instead of below <250 seconds, according to standard treatment guidelines to reduce heparin administration when using an αIIbβ3 inhibitor -Adapt exclusion criteria regarding COVID-19 infection. Instead of suspicion for COVID-19 infection it is preferred to only exclude confirmed COVID-19 infection. There were a number of exclusions based on this criterion of suspected infection, whereas afterwards these patients appeared not to be infected and could have participated in the trial. -Adapt inclusion criteria regarding persistent vs ongoing ST elevation. Has been adapted to include subjects with resolved ST elevation as well, as for the response to the study drug it does not matter whether ST elevation is persistent or has been resolved. -Remove exclusion criterium regarding de novo AF. De novo AF has been removed, as this criterion was included in order to exclude type 2 myocardial infarction, which is already an exclusion criterion (no. 2), therefore this criterion is redundant. -VerifyNow measurement now includes additional BASE channel; P2Y12 Test cartridges instead of PRU. This channel identifies the percentage inhibition directly related to the study drug, while filtering the inhibitory effects from the P2Y12 blocker ticagrelor.

    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.
    N/A.
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