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    Clinical Trial Results:
    An open-label, dose escalation, single-dose administration, multi-center phase I/II trial of FG001 (an imaging agent), in patients with glioblastoma scheduled for neurosurgery

    Summary
    EudraCT number
    		 2020-003089-38
    Trial protocol
    		 DK   SE  
    Global end of trial date
    12 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2024
    First version publication date
    27 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FG001-CT-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FluoGuiode A/s
    Sponsor organisation address
    Ole Maaløes Vej 3, København N, Denmark, 2200
    Public contact
    Morten Albrechtsen, FluoGuide A/S, ma@fluoguide.com
    Scientific contact
    Morten Albrechtsen, FluoGuide A/S, ma@fluoguide.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
    10 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I: 1. To evaluate the safety and tolerability of single i.v. doses of FG001 in patients with malignant glioma scheduled for surgery 2. To establish the optimal dose for imaging of FG001 in patients with malignant glioma Phase II: 1. To evaluate the efficacy of FG001 in patients with malignant glioma undergoing surgery and to compare it with the efficacy of 5-ALA in patients with malignant glioma undergoing surgery
    Protection of trial subjects
    The trial patients were given ample time to consider participation in the trial before the consent was obtained. The informed consent documents were signed and dated by each patient and the Investigator, who had provided the information to the patient regarding the trial, before these patients had been exposed to any trial-related procedures, including screening tests for eligibility. All patients received a copy of the patient information and the signed ICF. If new information potentially relevant to the trial patient’s willingness to continue participation in the trial became available, a new patient information and ICF were provided to the IECs (and regulatory authorities, if required) for review and approval. The trial patients were informed about this new information and new consents were obtained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Denmark: 59
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    40
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During screening, eligible patients with the suspicion of the primary malignant glioma, as judged by MRI, were included in the trial. Each participant received a unique screening number which was entered in a screening log. At baseline visit an evaluation of their complete medical history, vital signs, etc. was performed.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase I
    Arm description
    		 Phase I was an open-label, non-randomized FiH phase with single-dose administration of FG001. It consisted of the dose escalation and dose elaboration parts, conducted at 1 site in Denmark. 40 patients were treated in Phase I, where all patients received both 5-ALA (as standard of care) and FG001.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    Other name
    ICG-Glu-Glu-AE05
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The Investigational Medicinal Product (IMP) FG001 Drug Product i.v. (FG001 DP) was delivered in vials each vial containing 5.2 mg of freeze-dried FG001 for reconstitution with 5.0 m of sterile water for injection (sWfI) before use. All patients received a single dose of reconstituted IMP through a slow i.v. injection lasting for up to 10 minutes. In phase I, FG001 was administered i.v. in the morning on the day of the surgery (dose escalation) or in the evening the day before the surgery (dose elaboration).

    Investigational medicinal product name
    5-ALA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    A commercially available 5-ALA product for phases I and II (Gliolan® for oral administration) was purchased and supplied by the hospital. 5-ALA was administered in the morning, 2-4 hours before the surgery as an oral solution.

    Arm title
    		 Phase II - 5-ALA
    Arm description
    		 In Phase II, 24 patients were randomized to FG001 and 5-ALA arms. Randomization was performed after baseline assessments and before any trial treatment administration. 5-ALA served as the active comparator to FG001, where patients were randomized to either FG001 or 5-ALA treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    5-ALA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    A commercially available 5-ALA product for phases I and II (Gliolan® for oral administration) was purchased and supplied by the hospital. 5-ALA was administered in the morning, 2-4 hours before the surgery as an oral solution.

    Arm title
    		 Phase II - FG001
    Arm description
    		 In Phase II, 24 patients were randomized to FG001 and 5-ALA arms. Randomization was performed after baseline assessments and before any trial treatment administration. FG001 served as the experimetnal arm in Part II, where patients were randomized to either FG001 or 5-ALA treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    Other name
    ICG-Glu-Glu-AE05
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The Investigational Medicinal Product (IMP) FG001 Drug Product i.v. (FG001 DP) was delivered in vials each vial containing 5.2 mg of freeze-dried FG001 for reconstitution with 5.0 m of sterile water for injection (sWfI) before use. All patients randomized to FG001 received a single dose of reconstituted IMP through a slow i.v. injection lasting for up to 10 minutes. In phase II, FG001 was administered i.v. in the evening the day before the surgery. Patients received the planned dose of FG001 (36 mg per patient).

    Number of subjects in period 1
    		Phase I Phase II - 5-ALA Phase II - FG001
    Started
    40
    12
    12
    Completed
    40
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase I
    Reporting group description
    		 Phase I was an open-label, non-randomized FiH phase with single-dose administration of FG001. It consisted of the dose escalation and dose elaboration parts, conducted at 1 site in Denmark. 40 patients were treated in Phase I, where all patients received both 5-ALA (as standard of care) and FG001.

    Reporting group title
    Phase II - 5-ALA
    Reporting group description
    		 In Phase II, 24 patients were randomized to FG001 and 5-ALA arms. Randomization was performed after baseline assessments and before any trial treatment administration. 5-ALA served as the active comparator to FG001, where patients were randomized to either FG001 or 5-ALA treatment.

    Reporting group title
    Phase II - FG001
    Reporting group description
    		 In Phase II, 24 patients were randomized to FG001 and 5-ALA arms. Randomization was performed after baseline assessments and before any trial treatment administration. FG001 served as the experimetnal arm in Part II, where patients were randomized to either FG001 or 5-ALA treatment.

    Reporting group values
    		 Phase I Phase II - 5-ALA Phase II - FG001 Total
    Number of subjects
    		 40 12 12 64
    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
        arithmetic mean (standard deviation)
    		 58.2 ( 10 ) 66.6 ( 6.5 ) 58.3 ( 13.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 4 4 24
        Male
    		 24 8 8 40
    Subject analysis sets

    Subject analysis set title
    Phase I: Escalation - Cohort 1 (1mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001: 1 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 2 (2mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 2mg

    Subject analysis set title
    Phase I: Escalation - Cohort 3 (4mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 4mg

    Subject analysis set title
    Phase I: Escalation - Cohort 4 (8mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 8mg

    Subject analysis set title
    Phase I: Escalation - Cohort 5 (16mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 16 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 6 (24mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 24 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 7 (36mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 36 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 8 (48mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 48 mg

    Subject analysis set title
    Phase I: Elaboration - Cohort 1 (16mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 16 mg

    Subject analysis set title
    Phase I: Elaboration - Cohort 2 (36mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 36 mg

    Subject analysis set title
    Phase I: Elaboration - Cohort 3 (48mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 48 mg

    Subject analysis sets values
    		 Phase I: Escalation - Cohort 1 (1mg) Phase I: Escalation - Cohort 2 (2mg) Phase I: Escalation - Cohort 3 (4mg) Phase I: Escalation - Cohort 4 (8mg) Phase I: Escalation - Cohort 5 (16mg) Phase I: Escalation - Cohort 6 (24mg) Phase I: Escalation - Cohort 7 (36mg) Phase I: Escalation - Cohort 8 (48mg) Phase I: Elaboration - Cohort 1 (16mg) Phase I: Elaboration - Cohort 2 (36mg) Phase I: Elaboration - Cohort 3 (48mg)
    Number of subjects
    3
    3
    3
    4
    3
    3
    3
    4
    5
    5
    4
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    66.3 ( 9.8 )
    60 ( 5.1 )
    60.3 ( 8.1 )
    57.8 ( 7.5 )
    49.0 ( 5.2 )
    60.3 ( 9.5 )
    57.7 ( 13.3 )
    60.5 ( 3.9 )
    58.0 ( 8.5 )
    62.6 ( 12.4 )
    47.8 ( 10.7 )
    Gender categorical
    Units: Subjects
        Female
    3
    1
    1
    2
    1
    1
    1
    3
    1
    1
    1
        Male
    0
    3
    3
    2
    2
    2
    2
    1
    4
    4
    3

    End points

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    End points reporting groups
    Reporting group title
    Phase I
    Reporting group description
    		 Phase I was an open-label, non-randomized FiH phase with single-dose administration of FG001. It consisted of the dose escalation and dose elaboration parts, conducted at 1 site in Denmark. 40 patients were treated in Phase I, where all patients received both 5-ALA (as standard of care) and FG001.

    Reporting group title
    Phase II - 5-ALA
    Reporting group description
    		 In Phase II, 24 patients were randomized to FG001 and 5-ALA arms. Randomization was performed after baseline assessments and before any trial treatment administration. 5-ALA served as the active comparator to FG001, where patients were randomized to either FG001 or 5-ALA treatment.

    Reporting group title
    Phase II - FG001
    Reporting group description
    		 In Phase II, 24 patients were randomized to FG001 and 5-ALA arms. Randomization was performed after baseline assessments and before any trial treatment administration. FG001 served as the experimetnal arm in Part II, where patients were randomized to either FG001 or 5-ALA treatment.

    Subject analysis set title
    Phase I: Escalation - Cohort 1 (1mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001: 1 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 2 (2mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 2mg

    Subject analysis set title
    Phase I: Escalation - Cohort 3 (4mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 4mg

    Subject analysis set title
    Phase I: Escalation - Cohort 4 (8mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 8mg

    Subject analysis set title
    Phase I: Escalation - Cohort 5 (16mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 16 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 6 (24mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 24 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 7 (36mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 36 mg

    Subject analysis set title
    Phase I: Escalation - Cohort 8 (48mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 48 mg

    Subject analysis set title
    Phase I: Elaboration - Cohort 1 (16mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 16 mg

    Subject analysis set title
    Phase I: Elaboration - Cohort 2 (36mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 36 mg

    Subject analysis set title
    Phase I: Elaboration - Cohort 3 (48mg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FG001 48 mg

    Primary: TBR (mean) values obtained with ORBEYE and ZEISS Pentero

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    End point title
    		 TBR (mean) values obtained with ORBEYE and ZEISS Pentero [1]
    End point description
    The trial was descriptive in nature, and no confirmatory hypotheses were tested. TBR = Tumor to Background Ratio.
    End point type
    Primary
    End point timeframe
    Duration of the Phase I part of the trial.
    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: The trial was descriptive in nature, and no confirmatory hypotheses were tested.
    End point values
    		 Phase I: Escalation - Cohort 5 (16mg) Phase I: Escalation - Cohort 6 (24mg) Phase I: Escalation - Cohort 7 (36mg) Phase I: Escalation - Cohort 8 (48mg) Phase I: Elaboration - Cohort 1 (16mg) Phase I: Elaboration - Cohort 2 (36mg) Phase I: Elaboration - Cohort 3 (48mg)
    Number of subjects analysed
    3 [2]
    3 [3]
    3 [4]
    2 [5]
    4 [6]
    4 [7]
    4 [8]
    Units: TBR
    arithmetic mean (full range (min-max))
        ORBEYE
    1.5 (1.3 to 1.7)
    1.43 (1.2 to 1.7)
    1.53 (1.4 to 1.6)
    1.4 (1.4 to 1.4)
    1.5 (1.3 to 1.8)
    1.9 (1.7 to 2.2)
    1.4 (1.3 to 1.5)
        ZEISS
    0 (0 to 0)
    2.1 (2.1 to 2.1)
    1.4 (1.4 to 1.4)
    1.6 (1.5 to 1.7)
    0 (0 to 0)
    2.65 (1.9 to 3.7)
    2.45 (2.2 to 2.8)
    Notes
    [2] - n = 3 ORBEYE
    [3] - n = 3 ORBEYE, n = 2 ZEISS
    [4] - n = 3 ORBEYE, n = 1 ZEISS
    [5] - n = 2 ORBEYE, n = 2 ZEISS
    [6] - n = 4 ORBEYE
    [7] - n = 4 ORBEYE, n = 4 ZEISS
    [8] - n = 4 ORBEYE, n = 4 ZEISS
    No statistical analyses for this end point

    Primary: Indeterminated or unexpected fluorescent tissue

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    End point title
    		 Indeterminated or unexpected fluorescent tissue [9] [10]
    End point description
    This endpoint corresponded to the occurrence of at least 1 indeterminated or unexpected fluorescent tissue, where FG001- or 5-ALA-induced fluorescence was consistent with the histopathological assessment. This endpoint was assessed by calculating the proportion of patients with favorable outcome. The outcome was considered favorable if indeterminated or unexpected fluorescence was observed in the EOS cavity and the subsequent histopathological assessment confirmed that biopsies taken from the fluorescent area of this cavity contained tumor cells.
    End point type
    Primary
    End point timeframe
    Duration of Phase II part of trial.
    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: The trial was descriptive in nature, and no confirmatory hypotheses were tested.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results are provided for the sub-groups, where all sub groups belong to Phase I arm.
    End point values
    		 Phase II - 5-ALA Phase II - FG001
    Number of subjects analysed
    12
    12
    Units: Patients
    12
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire duration of trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Phase I cohorts
    Reporting group description
    		 -

    Reporting group title
    Phase II cohorts
    Reporting group description
    		 -

    Serious adverse events
    		 Phase I cohorts Phase II cohorts
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 40 (17.50%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Extradural haematoma
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phase I cohorts Phase II cohorts
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 40 (100.00%)
    24 / 24 (100.00%)
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    21 / 40 (52.50%)
    9 / 24 (37.50%)
         occurrences all number
    21
    9
    Electrocardiogram QT prolonged
         subjects affected / exposed
    5 / 40 (12.50%)
    0 / 24 (0.00%)
         occurrences all number
    5
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 40 (12.50%)
    2 / 24 (8.33%)
         occurrences all number
    5
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 24 (12.50%)
         occurrences all number
    4
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 40 (2.50%)
    4 / 24 (16.67%)
         occurrences all number
    1
    4
    Blood chloride decreased
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    3
    PCO2 increased
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    3
    PO2 increased
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    3
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Blood lactic acid increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Procedural headache
         subjects affected / exposed
    19 / 40 (47.50%)
    5 / 24 (20.83%)
         occurrences all number
    19
    5
    Pneumocephalus
         subjects affected / exposed
    11 / 40 (27.50%)
    7 / 24 (29.17%)
         occurrences all number
    11
    7
    Incision site pain
         subjects affected / exposed
    0 / 40 (0.00%)
    11 / 24 (45.83%)
         occurrences all number
    0
    11
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 24 (12.50%)
         occurrences all number
    3
    3
    Hypotension
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 24 (4.17%)
         occurrences all number
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 40 (27.50%)
    3 / 24 (12.50%)
         occurrences all number
    11
    3
    Dizziness
         subjects affected / exposed
    8 / 40 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    8
    0
    Hemianopia
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 24 (0.00%)
         occurrences all number
    3
    0
    Hemiparesis
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 24 (8.33%)
         occurrences all number
    3
    2
    Aphasia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Diplopia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Dysaesthesia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorder
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Hemianopia homonymous
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 40 (22.50%)
    3 / 24 (12.50%)
         occurrences all number
    9
    3
    Pyrexia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    24 / 40 (60.00%)
    2 / 24 (8.33%)
         occurrences all number
    24
    2
    Vomiting
         subjects affected / exposed
    6 / 40 (15.00%)
    0 / 24 (0.00%)
         occurrences all number
    6
    0
    Constipation
         subjects affected / exposed
    5 / 40 (12.50%)
    0 / 24 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 24 (0.00%)
         occurrences all number
    4
    0
    Confusional state
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Hallucination, visual
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Pain in jaw
         subjects affected / exposed
    6 / 40 (15.00%)
    2 / 24 (8.33%)
         occurrences all number
    6
    2
    Neck pain
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    28 / 40 (70.00%)
    1 / 24 (4.17%)
         occurrences all number
    28
    1
    Hypoalbuminaemia
         subjects affected / exposed
    24 / 40 (60.00%)
    13 / 24 (54.17%)
         occurrences all number
    24
    13
    Hypocalcaemia
         subjects affected / exposed
    14 / 40 (35.00%)
    12 / 24 (50.00%)
         occurrences all number
    14
    12
    Hypermagnesaemia
         subjects affected / exposed
    13 / 40 (32.50%)
    1 / 24 (4.17%)
         occurrences all number
    13
    1
    Hypophosphataemia
         subjects affected / exposed
    8 / 40 (20.00%)
    9 / 24 (37.50%)
         occurrences all number
    8
    9
    Hypokalaemia
         subjects affected / exposed
    6 / 40 (15.00%)
    4 / 24 (16.67%)
         occurrences all number
    6
    4
    Hyponatraemia
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 24 (16.67%)
         occurrences all number
    3
    4
    Hyperkalaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    5 / 24 (20.83%)
         occurrences all number
    2
    5
    Hyperphosphataemia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Acidosis
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Aug 2020
    Protocol version 2.0, amendment as response to GNA comments from the DKMA.
    25 Mar 2021
    Protocol version 3.0, amendment to include dose elaboration phase.
    08 Sep 2021
    Protocol version 4.0, amendment to include morning administration.
    05 Aug 2022
    Protocol version 5.1, amendment to move into Phase II of the trial.
    18 Jan 2023
    Protocol version 6.0, amendment to change the secondary objective of the trial.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36416941
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