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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease

    Summary
    EudraCT number
    		 2018-003337-15
    Trial protocol
    		 HU   SK   ES  
    Global end of trial date
    06 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2025
    First version publication date
    20 Apr 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLR_18_06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03655236
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sun Pharma Advanced Research Company Limited (SPARC)
    Sponsor organisation address
    17/B, Mahal Industrial Estate, Mahakali Caves Road, Mumbai, India, 400093
    Public contact
    Orest Hurko, Sun Pharma Advanced Research Company Limited (SPARC), Orest.Hurko@sparcmail.com
    Scientific contact
    Orest Hurko, Sun Pharma Advanced Research Company Limited (SPARC), Orest.Hurko@sparcmail.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
    06 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine if K0706 reduces the rate of progression of early-stage Parkinson's disease (PD) versus placebo over 40 weeks, as assessed by the MDS-UPDRS (Movement Disorder Society – Unified Parkinson's Disease Rating Scale) Part III (motor examination) total score.
    Protection of trial subjects
    The trial and site activities were monitored according to the ICH-GCP guidelines considering every aspect of the trial, ensuring that the rights, safety and well-being of patients are protected and consistent with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2019
    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
    India: 89
    Country: Number of subjects enrolled
    United States: 221
    Country: Number of subjects enrolled
    Poland: 80
    Country: Number of subjects enrolled
    Slovakia: 21
    Country: Number of subjects enrolled
    Spain: 85
    Country: Number of subjects enrolled
    Hungary: 17
    Worldwide total number of subjects
    513
    EEA total number of subjects
    203
    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)
    241
    From 65 to 84 years
    266
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects aged ≥ 50 years in whom an initial diagnosis of PD had been made within three years of the Screening visit, who score on a modified Hoehn and Yahr stage ≤ 2 and who are not on any dopaminergic treatment other than MAO-B inhibitors will be eligible for screening.

    Period 1
    Period 1 title
    Subject Disposition in Part 1 Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 K0706, low dose
    Arm description
    		 Part 1; low dose K0706
    Arm type
    		 Experimental

    Investigational medicinal product name
    K0706
    Investigational medicinal product code
    Other name
    Vodobatinib
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The study drug will be administered in the form of a 96 mg capsule or 192 mg powder; subjects will be instructed to take the study drug orally once daily. They should not eat food two hours prior and at least one (but ideally two) hour after dosing. For the powder formulation, the entire contents of one sachet are to be added to a glass of water (at least 4 oz. [120 mL]), mixed uniformly using a spoon or other stirrer, and ingested promptly. Any residual powder remaining in the glass or on the stirrer should be mixed with additional water and consumed to ensure ingestion of the total dose.

    Arm title
    		 K0706, high dose
    Arm description
    		 Part 1; high dose K0706
    Arm type
    		 Experimental

    Investigational medicinal product name
    K0706
    Investigational medicinal product code
    Other name
    Vodobatinib
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The study drug will be administered in the form of a 96 mg capsule or 192 mg powder; subjects will be instructed to take the study drug orally once daily. They should not eat food two hours prior and at least one (but ideally two) hour after dosing. For the powder formulation, the entire contents of one sachet are to be added to a glass of water (at least 4 oz. [120 mL]), mixed uniformly using a spoon or other stirrer, and ingested promptly. Any residual powder remaining in the glass or on the stirrer should be mixed with additional water and consumed to ensure ingestion of the total dose.

    Arm title
    		 Placebo
    Arm description
    		 Part 1; placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The study drug will be administered in the form of a 96 mg capsule or 192 mg powder; subjects will be instructed to take the study drug orally once daily. They should not eat food two hours prior and at least one (but ideally two) hour after dosing. For the powder formulation, the entire contents of one sachet are to be added to a glass of water (at least 4 oz. [120 mL]), mixed uniformly using a spoon or other stirrer, and ingested promptly. Any residual powder remaining in the glass or on the stirrer should be mixed with additional water and consumed to ensure ingestion of the total dose. The placebo formulation will contain the same excipients as that of the K0706 formulation and match the K0706 formulation in shape, size, and color.

    Number of subjects in period 1
    		K0706, low dose K0706, high dose Placebo
    Started
    171
    174
    168
    Completed
    114
    66
    120
    Not completed
    57
    108
    48
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    11
    16
    6
         Physician decision
    -
    3
    2
         Study terminated by Sponsor
    12
    8
    13
         Adverse event, non-fatal
    25
    55
    12
         Requires prohibited medication
    4
    5
    3
         Poor compliance
    -
    2
    -
         Not specified
    -
    2
    2
         Withdrawal by Subject
    -
    5
    3
         Lost to follow-up
    1
    3
    2
         Parkinson's disease progression
    2
    8
    5
         Protocol deviation
    1
    1
    -
    Period 2
    Period 2 title
    Subject Disposition in Part 2 Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 K0706, low dose
    Arm description
    		 Part 2; K0706 low dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    K0706
    Investigational medicinal product code
    Other name
    Vodobatinib
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The study drug will be administered in the form of a 96 mg capsule or 192 mg powder; subjects will be instructed to take the study drug orally once daily. They should not eat food two hours prior and at least one (but ideally two) hour after dosing. For the powder formulation, the entire contents of one sachet are to be added to a glass of water (at least 4 oz. [120 mL]), mixed uniformly using a spoon or other stirrer, and ingested promptly. Any residual powder remaining in the glass or on the stirrer should be mixed with additional water and consumed to ensure ingestion of the total dose.

    Arm title
    		 K0706, high dose
    Arm description
    		 Part 2, high dose; includes subjects from the prior Placebo arm, who were transitioned to K0706 High Dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    K0706
    Investigational medicinal product code
    Other name
    Vodobatinib
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The study drug will be administered in the form of a 96 mg capsule or 192 mg powder; subjects will be instructed to take the study drug orally once daily. They should not eat food two hours prior and at least one (but ideally two) hour after dosing. For the powder formulation, the entire contents of one sachet are to be added to a glass of water (at least 4 oz. [120 mL]), mixed uniformly using a spoon or other stirrer, and ingested promptly. Any residual powder remaining in the glass or on the stirrer should be mixed with additional water and consumed to ensure ingestion of the total dose.

    Arm title
    		 Placebo
    Arm description
    		 Part 2 placebo arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The study drug will be administered in the form of a 96 mg capsule or 192 mg powder; subjects will be instructed to take the study drug orally once daily. They should not eat food two hours prior and at least one (but ideally two) hour after dosing. For the powder formulation, the entire contents of one sachet are to be added to a glass of water (at least 4 oz. [120 mL]), mixed uniformly using a spoon or other stirrer, and ingested promptly. Any residual powder remaining in the glass or on the stirrer should be mixed with additional water and consumed to ensure ingestion of the total dose. The placebo formulation will contain the same excipients as that of the K0706 formulation and match the K0706 formulation in shape, size, and color.

    Number of subjects in period 2 [1] [2]
    		K0706, low dose K0706, high dose Placebo
    Started
    72
    21
    77
    Completed
    36
    29
    27
    Not completed
    36
    19
    50
         Consent withdrawn by subject
    5
    1
    12
         Study terminated by Sponsor
    18
    11
    13
         Adverse event, non-fatal
    2
    5
    12
         Requires prohibited medication
    3
    1
    5
         Not specified
    1
    -
    -
         Withdrawal by Subject
    1
    1
    2
         Lost to follow-up
    1
    -
    -
         Parkinson's disease progression
    4
    -
    2
         Protocol deviation
    1
    -
    4
    Joined
    0
    27
    0
         Transferred in from other group/arm
    -
    27
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 at Week 40.
    [2] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
    Justification: Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 at Week 40.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Subject Disposition in Part 1 Period
    Reporting group description
    		 -

    Reporting group values
    		 Subject Disposition in Part 1 Period Total
    Number of subjects
    		 513 513
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 241 241
        From 65-84 years
    		 266 266
        85 years and over
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ( 8.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 179 179
        Male
    		 334 334

    End points

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    End points reporting groups
    Reporting group title
    K0706, low dose
    Reporting group description
    		 Part 1; low dose K0706

    Reporting group title
    K0706, high dose
    Reporting group description
    		 Part 1; high dose K0706

    Reporting group title
    Placebo
    Reporting group description
    		 Part 1; placebo
    Reporting group title
    K0706, low dose
    Reporting group description
    		 Part 2; K0706 low dose

    Reporting group title
    K0706, high dose
    Reporting group description
    		 Part 2, high dose; includes subjects from the prior Placebo arm, who were transitioned to K0706 High Dose

    Reporting group title
    Placebo
    Reporting group description
    		 Part 2 placebo arm

    Primary: Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score.

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    End point title
    		 Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score. [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 40
    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: Calculated based on MDS-UPDRS.
    End point values
    		 K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    164
    162
    161
    Units: Score on a scale
        arithmetic mean (standard deviation)
    1.5 ( 8.77 )
    1.0 ( 7.58 )
    -1.0 ( 8.13 )
    No statistical analyses for this end point

    Primary: Incidence of Treatment-emergent Adverse Events

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    End point title
    		 Incidence of Treatment-emergent Adverse Events [2]
    End point description
    End point type
    Primary
    End point timeframe
    Week 80
    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: Calculated based on the number of study participants.
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    171
    173
    167
    72
    40
    77
    Units: Participants
    131
    150
    124
    37
    24
    61
    No statistical analyses for this end point

    Secondary: Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Parts II and III Total Scores Part 2: Change From Week 40 to Week 76 in the Sum of the MDS-UPDRS Part III Scores

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    End point title
    		 Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Parts II and III Total Scores Part 2: Change From Week 40 to Week 76 in the Sum of the MDS-UPDRS Part III Scores
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    164
    162
    161
    Units: Score on a scale
        arithmetic mean (standard deviation)
    2.6 ( 10.83 )
    2.7 ( 9.72 )
    -0.6 ( 9.53 )
    No statistical analyses for this end point

    Secondary: Time From First Dose in Part 1 to Initiation of Symptomatic PD Medications

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    End point title
    		 Time From First Dose in Part 1 to Initiation of Symptomatic PD Medications
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Week 40 and Part 2: Week 80
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    164 [3]
    162 [4]
    161 [5]
    70 [6]
    35 [7]
    71 [8]
    Units: Participants
    149
    129
    144
    60
    33
    57
    Notes
    [3] - Part 1
    [4] - Part 1
    [5] - Part 1
    [6] - Part 2
    [7] - Part 2
    [8] - Part 2
    No statistical analyses for this end point

    Secondary: Change in Health Related Quality of Life as Measured by the European Quality of Life Questionnaire 5 Level Version

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    End point title
    		 Change in Health Related Quality of Life as Measured by the European Quality of Life Questionnaire 5 Level Version
    End point description
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    89
    56
    97
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.0419 ( 0.11060 )
    -0.0531 ( 0.16289 )
    -0.0140 ( 0.10787 )
    No statistical analyses for this end point

    Secondary: Change in Clinician Global Impression Severity

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    End point title
    		 Change in Clinician Global Impression Severity
    End point description
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    104
    61
    103
    Units: Score on a scale
        arithmetic mean (standard deviation)
    0.2 ( 0.68 )
    0.0 ( 0.74 )
    0.2 ( 0.91 )
    No statistical analyses for this end point

    Secondary: Change in the Scales for Outcomes in Parkinson's Disease - Autonomic Questionnaire - Page

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    End point title
    		 Change in the Scales for Outcomes in Parkinson's Disease - Autonomic Questionnaire - Page
    End point description
    Data Not Reported
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    164
    162
    161
    Units: NA
    105
    64
    103
    No statistical analyses for this end point

    Secondary: Level of K0706

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    End point title
    		 Level of K0706
    End point description
    Data not captured
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    Units: NA
    Notes
    [9] - Data not captured
    [10] - Data not captured
    [11] - Data not captured
    [12] - Data not captured
    [13] - Data not captured
    [14] - Data not captured
    No statistical analyses for this end point

    Secondary: Exploratory Outcome: Effect of K0706 on Dopamine Cell Health in Parkinson's Disease as Detected Via Dopamine Transporter Single Photon Emission Computed Tomography (DaT SPECT) Brain Imaging

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    End point title
    		 Exploratory Outcome: Effect of K0706 on Dopamine Cell Health in Parkinson's Disease as Detected Via Dopamine Transporter Single Photon Emission Computed Tomography (DaT SPECT) Brain Imaging
    End point description
    Data not captured
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    Units: NA
    Notes
    [15] - Data not captured
    [16] - Data not captured
    [17] - Data not captured
    [18] - Data not captured
    [19] - Data not captured
    [20] - Data not captured
    No statistical analyses for this end point

    Secondary: CSF K0706 Levels Progression or Target Engagement of K0706.

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    End point title
    		 CSF K0706 Levels Progression or Target Engagement of K0706.
    End point description
    Data not captured
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    Units: NA
    Notes
    [21] - Data not captured
    [22] - Data not captured
    [23] - Data not captured
    [24] - Data not captured
    [25] - Data not captured
    [26] - Data not captured
    No statistical analyses for this end point

    Secondary: Brain DaT SPECT - an Imaging Tool That is a Marker of Dopaminergic Cell Health.

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    End point title
    		 Brain DaT SPECT - an Imaging Tool That is a Marker of Dopaminergic Cell Health.
    End point description
    Data not captured
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    Units: NA
    Notes
    [27] - Data not captured
    [28] - Data not captured
    [29] - Data not captured
    [30] - Data not captured
    [31] - Data not captured
    [32] - Data not captured
    No statistical analyses for this end point

    Secondary: Blood K0706 Levels

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    End point title
    		 Blood K0706 Levels
    End point description
    Data not captured
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    Units: NA
    Notes
    [33] - Data not captured
    [34] - Data not captured
    [35] - Data not captured
    [36] - Data not captured
    [37] - Data not captured
    [38] - Data not captured
    No statistical analyses for this end point

    Secondary: Skin Punch Biopsy

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    End point title
    		 Skin Punch Biopsy
    End point description
    Data not captured
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 K0706, low dose K0706, high dose Placebo K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    0 [43]
    0 [44]
    Units: NA
    Notes
    [39] - Data not captured
    [40] - Data not captured
    [41] - Data not captured
    [42] - Data not captured
    [43] - Data not captured
    [44] - Data not captured
    No statistical analyses for this end point

    Secondary: Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Parts II and III Total Scores Part 2: Change From Week 40 to Week 76 in the Sum of the MDS-UPDRS Part III Scores

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    End point title
    		 Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Parts II and III Total Scores Part 2: Change From Week 40 to Week 76 in the Sum of the MDS-UPDRS Part III Scores
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2: Week 76
    End point values
    		 K0706, low dose K0706, high dose Placebo
    Number of subjects analysed
    30
    18
    25
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Tremor Subscore
    0.4 ( 1.87 )
    -0.9 ( 2.54 )
    -0.4 ( 2.68 )
        Bradykinesia Subscore
    -0.7 ( 2.25 )
    -0.1 ( 0.83 )
    0.0 ( 2.20 )
        Rigidity Subscore
    1.7 ( 4.46 )
    0.2 ( 3.81 )
    0.8 ( 4.12 )
        Axial Symptoms Subscore
    0.5 ( 1.22 )
    0.4 ( 1.15 )
    0.0 ( 1.37 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-related TEAEs that occurred more than 30 days after the last dose date are included for reporting
    Adverse event reporting additional description
    Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Part 1: K0706 low-dose
    Reporting group description
    		 Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance.

    Reporting group title
    Part 1: K0706 high-dose
    Reporting group description
    		 Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance.

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Part 1; Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance.

    Reporting group title
    Part 2: K0706 low-dose
    Reporting group description
    		 Part 2; Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance.

    Reporting group title
    Part 2: K0706 high-dose
    Reporting group description
    		 Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance.

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Multiple instances of occurrence of the same AE in the same patient will be considered as a single instance; part 2: Prior Placebo transitioned to K0706 High Dose

    Serious adverse events
    		 Part 1: K0706 low-dose Part 1: K0706 high-dose Part 1: Placebo Part 2: K0706 low-dose Part 2: K0706 high-dose Part 2: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 171 (1.17%)
    7 / 173 (4.05%)
    5 / 167 (2.99%)
    3 / 72 (4.17%)
    2 / 67 (2.99%)
    4 / 77 (5.19%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Parkinsonism
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic Intracranial Hypertension
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal perforation
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Part 1: K0706 low-dose Part 1: K0706 high-dose Part 1: Placebo Part 2: K0706 low-dose Part 2: K0706 high-dose Part 2: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 171 (46.78%)
    114 / 173 (65.90%)
    48 / 167 (28.74%)
    8 / 72 (11.11%)
    46 / 67 (68.66%)
    0 / 77 (0.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    2 / 171 (1.17%)
    4 / 173 (2.31%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 173 (0.58%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    3
    1
    1
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Early satiety
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Face oedema
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    General physical health deterioration
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 171 (0.00%)
    4 / 173 (2.31%)
    2 / 167 (1.20%)
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    5
    2
    1
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Chills
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Facial pain
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Mucosal dryness
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Asthenia
         subjects affected / exposed
    1 / 171 (0.58%)
    5 / 173 (2.89%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    1
    5
    0
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pulmonary mass
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    1 / 171 (0.58%)
    3 / 173 (1.73%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Aphonia
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Affect lability
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Mood altered
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Nightmare
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 171 (0.00%)
    3 / 173 (1.73%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    Hallucination, visual
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Agitation
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Impulse-control disorder
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 171 (1.17%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    2
    2
    0
    0
    1
    0
    Abnormal dreams
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Affective disorder
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Investigations
    Liver function test increased
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Mean platelet volume decreased
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Platelet count increased
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Protein total increased
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 171 (0.58%)
    3 / 173 (1.73%)
    1 / 167 (0.60%)
    1 / 72 (1.39%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    1
    3
    2
    1
    2
    0
    Weight decreased
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Heart rate irregular
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Neurological symptom
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    2 / 167 (1.20%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Headache
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    6 / 171 (3.51%)
    5 / 173 (2.89%)
    5 / 167 (2.99%)
    1 / 72 (1.39%)
    3 / 67 (4.48%)
    0 / 77 (0.00%)
         occurrences all number
    6
    5
    6
    1
    3
    0
    Sciatica
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    2 / 171 (1.17%)
    1 / 173 (0.58%)
    3 / 167 (1.80%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    4
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Somnolence
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Speech disorder
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Taste disorder
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Dizziness
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    2 / 171 (1.17%)
    8 / 173 (4.62%)
    4 / 167 (2.40%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    2
    9
    6
    0
    2
    0
    Tremor
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    2 / 171 (1.17%)
    8 / 173 (4.62%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    3 / 67 (4.48%)
    0 / 77 (0.00%)
         occurrences all number
    2
    8
    1
    0
    3
    0
    Burning sensation
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 171 (0.00%)
    3 / 173 (1.73%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    0
    Leukopenia
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eye disorders
    Optic neuropathy
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Visual acuity reduced transiently
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Papilloedema
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    3 / 167 (1.80%)
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    3
    1
    1
    0
    Eye swelling
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    Swelling of eyelid
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Xerophthalmia
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Constipation
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    0 / 171 (0.00%)
    5 / 173 (2.89%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    0
    5
    1
    0
    2
    0
    Gastroesophageal reflux
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Anal incontinence
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Faeces soft
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Hiccups
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lip oedema
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Oral dysaesthesia
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tongue pruritus
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ulcerative gastritis
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Diarrhoea
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    13 / 171 (7.60%)
    13 / 173 (7.51%)
    2 / 167 (1.20%)
    1 / 72 (1.39%)
    3 / 67 (4.48%)
    0 / 77 (0.00%)
         occurrences all number
    13
    21
    3
    1
    3
    0
    Abdominal pain upper
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    2 / 171 (1.17%)
    5 / 173 (2.89%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    4 / 67 (5.97%)
    0 / 77 (0.00%)
         occurrences all number
    3
    6
    2
    0
    4
    0
    Dry mouth
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    2 / 167 (1.20%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    Nausea
         subjects affected / exposed
    13 / 171 (7.60%)
    14 / 173 (8.09%)
    6 / 167 (3.59%)
    2 / 72 (2.78%)
    3 / 67 (4.48%)
    0 / 77 (0.00%)
         occurrences all number
    14
    17
    6
    2
    3
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    3 / 67 (4.48%)
    0 / 77 (0.00%)
         occurrences all number
    1
    3
    0
    0
    3
    0
    Gastritis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    3 / 171 (1.75%)
    2 / 173 (1.16%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    0
    Abdominal pain
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    4 / 171 (2.34%)
    5 / 173 (2.89%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    4
    7
    1
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    3 / 171 (1.75%)
    0 / 173 (0.00%)
    2 / 167 (1.20%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    4
    0
    2
    0
    0
    0
    Gastric disorder
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastritis erosive
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Glossitis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 171 (0.00%)
    5 / 173 (2.89%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    6
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 171 (0.00%)
    6 / 173 (3.47%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    7
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    3 / 171 (1.75%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lip swelling
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rectal tenesmus
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Defaecation urgency
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infrequent bowel movements
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Butterfly rash
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rash macular
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    Rash
    Additional description: For Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    18 / 171 (10.53%)
    27 / 173 (15.61%)
    3 / 167 (1.80%)
    0 / 72 (0.00%)
    7 / 67 (10.45%)
    0 / 77 (0.00%)
         occurrences all number
    23
    30
    3
    0
    9
    0
    Pruritus
         subjects affected / exposed
    8 / 171 (4.68%)
    11 / 173 (6.36%)
    2 / 167 (1.20%)
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    9
    13
    2
    0
    2
    0
    Rash papular
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    1
    3
    0
    0
    2
    0
    Mucocutaneous rash
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 171 (0.58%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Erythema
    Additional description: For Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    7 / 171 (4.09%)
    17 / 173 (9.83%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    7 / 67 (10.45%)
    0 / 77 (0.00%)
         occurrences all number
    10
    18
    0
    0
    8
    0
    Alopecia
         subjects affected / exposed
    4 / 171 (2.34%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    3 / 67 (4.48%)
    0 / 77 (0.00%)
         occurrences all number
    4
    3
    0
    0
    5
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Madarosis
         subjects affected / exposed
    3 / 171 (1.75%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Keratosis pilaris
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 171 (0.58%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Erythema multiforme
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin depigmentation
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin reaction
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sunburn
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Calculus bladder
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Urinary hesitation
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Flank pain
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 171 (0.00%)
    6 / 173 (3.47%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    6
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    2 / 171 (1.17%)
    3 / 173 (1.73%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    2
    3
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 171 (0.00%)
    2 / 173 (1.16%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    1
    0
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Muscle rigidity
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    2 / 171 (1.17%)
    2 / 173 (1.16%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    0 / 77 (0.00%)
         occurrences all number
    3
    2
    0
    0
    2
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Urinary tract infection
    Additional description: For part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    3 / 171 (1.75%)
    4 / 173 (2.31%)
    5 / 167 (2.99%)
    0 / 72 (0.00%)
    4 / 67 (5.97%)
    0 / 77 (0.00%)
         occurrences all number
    4
    4
    7
    0
    4
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Influenza
    Additional description: Part 2: Prior Placebo transitioned to K0706 High Dose
         subjects affected / exposed
    2 / 171 (1.17%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    2 / 167 (1.20%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 171 (0.58%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 171 (0.00%)
    6 / 173 (3.47%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    1 / 167 (0.60%)
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 171 (0.00%)
    0 / 173 (0.00%)
    0 / 167 (0.00%)
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Sep 2019
    The protocol was amended due to the following reasons: (a.) Addition of new formulation: Powder for suspension (b.) Addition of new doses: 192 mg powder (low dose) and 384 mg powder (high dose)
    20 Jul 2021
    The study was amended because the study design was changed to add an optional long-term extension study.
    23 Oct 2023
    The protocol was amended because the primary endpoint was modified.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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