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    Clinical Trial Results:
    A 4-part Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of M254 in Healthy Volunteers and in Patients with Immune Thrombocytopenic Purpura

    Summary
    EudraCT number
    		 2018-003534-32
    Trial protocol
    		 NL   BE   HU   PL   ES   IT  
    Global end of trial date
    08 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2022
    First version publication date
    11 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MOM-M254-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03866577
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Momenta Pharmaceuticals, Inc.
    Sponsor organisation address
    301 Binney Street, Cambridge, United States, 02142
    Public contact
    Clinical Registry Group, Momenta Pharmaceuticals, Inc., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Momenta Pharmaceuticals, Inc., ClinicalTrialsEU@its.jnj.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
    08 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was: to assess the safety and tolerability of a single ascending dose of intravenous (IV) administration of M254 in healthy subjects (Part A); to assess the safety and tolerability of a single IV administration of M254 in immunethrombocytopenia (ITP) subjects compared to 1000 milligrams/kilogram (mg/kg) IV immunoglobulin (IVIg) (Part B); to assess the safety of a single IV administration of M254 compared to 1000 mg/kg of IVIg and characterize the pharmacodynamics (PD) of single IV administration of M254 compared to 1000 mg/kg IVIg (Part C); to assess the safety and tolerability of repeated IV administration of M254 in ITP subjects (Part D).
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki in place at the time of study conduct. The study was conducted in compliance with the International Council for Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) (European Medicines Agency [EMA]/Committee for Medicinal Products for Human Use [CHMP]/ICH/135/1995), and compliant with the European Union Clinical Trial Directive (EU CTD): Directive 2001/20/EC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jan 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
    Belgium: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Netherlands: 27
    Country: Number of subjects enrolled
    Poland: 15
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    45
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 50 enrolled subjects, 46 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Placebo
    Arm description
    		 Subjects received a single intravenous (IV) infusion of matching placebo on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of matching placebo was administered on Day 1.

    Arm title
    		 Part A: M254 3 milligrams/kilogram (mg/kg)
    Arm description
    		 Subjects received a single IV infusion of M254 3 mg/kg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 3 mg/kg was administered on Day 1.

    Arm title
    		 Part A: M254 10 mg/kg
    Arm description
    		 Subjects received a single IV infusion of M254 10 mg/kg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 10 mg/kg was administered on Day 1.

    Arm title
    		 Part A: M254 30 mg/kg
    Arm description
    		 Subjects received a single IV infusion of M254 30 mg/kg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 30 mg/kg was administered on Day 1.

    Arm title
    		 Part A: M254 60 mg/kg
    Arm description
    		 Subjects received a single IV infusion of M254 60 mg/kg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 60 mg/kg was administered on Day 1.

    Arm title
    		 Part A: M254 120 mg/kg
    Arm description
    		 Subjects received a single IV infusion of M254 120 mg/kg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 120 mg/kg was administered on Day 1.

    Arm title
    		 Part A: M254 250 mg/kg
    Arm description
    		 Subjects received a single IV infusion of M254 250 mg/kg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 250 mg/kg was administered on Day 1.

    Arm title
    		 Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg
    Arm description
    		 Subjects with immune thrombocytopenia purpura (ITP) received a single IV infusion of M254 20 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IVIg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of IVIg 1000 mg/kg was administered on Day 29.

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 20 mg/kg was administered on Day 1.

    Arm title
    		 Part B: M254 60 mg/kg and IVIg 1000 mg/kg
    Arm description
    		 Subjects with ITP received a single IV infusion of M254 60 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IVIg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of IVIg 1000 mg/kg was administered on Day 29.

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 60 mg/kg was administered on Day 1.

    Arm title
    		 Part B: M254 120 mg/kg and IVIg 1000 mg/kg
    Arm description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IVIg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of IVIg 1000 mg/kg was administered on Day 29.

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 120 mg/kg was administered on Day 1.

    Arm title
    		 Part B: M254 250 mg/kg and IVIg 1000 mg/kg
    Arm description
    		 Subjects with ITP received a single IV infusion of M254 250 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IVIg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of IVIg 1000 mg/kg was administered on Day 29.

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 250 mg/kg was administered on Day 1.

    Arm title
    		 Part C: M254 120 mg/kg and IVIg 1000 mg/kg
    Arm description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 120 mg/kg was administered on Day 1.

    Investigational medicinal product name
    IVIg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of IVIg 1000 mg/kg was administered on Day 29.

    Arm title
    		 Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Arm description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1 followed by a single IV infusion of M254 120 mg/kg on Day 29.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of M254 120 mg/kg was administered on Day 29.

    Investigational medicinal product name
    IVIg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single dose of IVIg 1000 mg/kg was administered on Day 1.

    Number of subjects in period 1
    		Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg and IVIg 1000 mg/kg Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Started
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    6
    5
    Completed
    7
    3
    3
    3
    3
    3
    3
    2
    4
    3
    2
    5
    5
    Not completed
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    1
    0
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
    -
         Not qualified for IVIg infusion
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Protocol deviation
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Subjects received a single intravenous (IV) infusion of matching placebo on Day 1.

    Reporting group title
    Part A: M254 3 milligrams/kilogram (mg/kg)
    Reporting group description
    		 Subjects received a single IV infusion of M254 3 mg/kg on Day 1.

    Reporting group title
    Part A: M254 10 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 10 mg/kg on Day 1.

    Reporting group title
    Part A: M254 30 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 30 mg/kg on Day 1.

    Reporting group title
    Part A: M254 60 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 60 mg/kg on Day 1.

    Reporting group title
    Part A: M254 120 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 120 mg/kg on Day 1.

    Reporting group title
    Part A: M254 250 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 250 mg/kg on Day 1.

    Reporting group title
    Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg
    Reporting group description
    		 Subjects with immune thrombocytopenia purpura (ITP) received a single IV infusion of M254 20 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 60 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 60 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 120 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 250 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 250 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part C: M254 120 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1 followed by a single IV infusion of M254 120 mg/kg on Day 29.

    Reporting group values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg and IVIg 1000 mg/kg Part C: IVIg 1000 mg/kg and M254 120 mg/kg Total
    Number of subjects
    		 7 3 3 3 3 3 3 2 5 5 2 6 5 50
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 7 3 3 3 3 3 3 2 5 5 2 3 3 45
        From 65 to 84 years
    		 0 0 0 0 0 0 0 0 0 0 0 3 2 5
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.9 ( 10.9 ) 31.3 ( 7.64 ) 32 ( 13.75 ) 27 ( 1 ) 29 ( 7.81 ) 32.7 ( 15.53 ) 24.3 ( 4.51 ) 44 ( 4.24 ) 51.8 ( 11.45 ) 44 ( 12.94 ) 54.5 ( 13.44 ) 58 ( 14.48 ) 60 ( 12.63 ) -
    Title for Gender
    Units: subjects
        Female
    		 4 1 2 2 0 2 2 1 3 4 1 2 2 26
        Male
    		 3 2 1 1 3 1 1 1 2 1 1 4 3 24

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Subjects received a single intravenous (IV) infusion of matching placebo on Day 1.

    Reporting group title
    Part A: M254 3 milligrams/kilogram (mg/kg)
    Reporting group description
    		 Subjects received a single IV infusion of M254 3 mg/kg on Day 1.

    Reporting group title
    Part A: M254 10 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 10 mg/kg on Day 1.

    Reporting group title
    Part A: M254 30 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 30 mg/kg on Day 1.

    Reporting group title
    Part A: M254 60 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 60 mg/kg on Day 1.

    Reporting group title
    Part A: M254 120 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 120 mg/kg on Day 1.

    Reporting group title
    Part A: M254 250 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 250 mg/kg on Day 1.

    Reporting group title
    Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg
    Reporting group description
    		 Subjects with immune thrombocytopenia purpura (ITP) received a single IV infusion of M254 20 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 60 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 60 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 120 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 250 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 250 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part C: M254 120 mg/kg and IVIg 1000 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 followed by a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1 followed by a single IV infusion of M254 120 mg/kg on Day 29.

    Subject analysis set title
    Part B: M254 20 mg/kg - M254 period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 milligrams/kilogram (mg/kg) on Day 1.

    Subject analysis set title
    Part B: M254 20 mg/kg - IVIg period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IV immunoglubulin (IVIg) 1000 mg/kg on Day 29.

    Subject analysis set title
    Part B: M254 60 mg/kg - M254 period‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of M254 60 mg/kg on Day 1.

    Subject analysis set title
    Part B: M254 60 mg/kg - IVIg period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Subject analysis set title
    Part B: M254 120 mg/kg - M254 period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1.

    Subject analysis set title
    Part B: M254 120 mg/kg - IVIg period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Subject analysis set title
    Part B: M254 250 mg/kg - M254 period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of M254 250 mg/kg on Day 1.

    Subject analysis set title
    Part B: M254 250 mg/kg - IVIg period‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Subject analysis set title
    Part C: M254 120 mg/kg and IVIg 1000 mg/kg - M254 period‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1.

    Subject analysis set title
    Part C: M254 120 mg/kg and IVIg 1000 mg/kg - IVIg period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Subject analysis set title
    Part C: IVIg 1000 mg/kg and M254 120 mg/kg - IVIg period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1.

    Subject analysis set title
    Part C: IVIg 1000 mg/kg and M254 120 mg/kg - M254 period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 29.

    Subject analysis set title
    Part C: M254 120 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1 or Day 29.

    Subject analysis set title
    Part C: IVIg 1000 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1 or Day 29.

    Primary: Parts A, B, and C: Number of Subjects with Adverse Events (AE) by Severity as a Measure of Safety and Tolerability

    		 Close Top of page
    End point title
    		 Parts A, B, and C: Number of Subjects with Adverse Events (AE) by Severity as a Measure of Safety and Tolerability [1] [2]
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Safety analysis set included all subjects who received at least 1 dose of M254 or intravenous immunoglobulin (IVIg) or placebo. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg - M254 period Part B: M254 20 mg/kg - IVIg period Part B: M254 60 mg/kg - M254 period‌ Part B: M254 60 mg/kg - IVIg period Part B: M254 120 mg/kg - M254 period Part B: M254 120 mg/kg - IVIg period Part B: M254 250 mg/kg - M254 period Part B: M254 250 mg/kg - IVIg period‌ Part C: M254 120 mg/kg and IVIg 1000 mg/kg - M254 period‌ Part C: M254 120 mg/kg and IVIg 1000 mg/kg - IVIg period Part C: IVIg 1000 mg/kg and M254 120 mg/kg - IVIg period Part C: IVIg 1000 mg/kg and M254 120 mg/kg - M254 period
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    2
    5
    4
    5
    3
    2
    2
    6
    5
    5
    5
    Units: subjects
    6
    3
    3
    3
    0
    3
    3
    1
    0
    2
    2
    1
    1
    0
    0
    1
    0
    2
    2
    No statistical analyses for this end point

    Primary: Parts A, B, and C: Number of Subjects with Clinically Significant Abnormalities in Clinical Laboratory Values

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    End point title
    		 Parts A, B, and C: Number of Subjects with Clinically Significant Abnormalities in Clinical Laboratory Values [3]
    End point description
    Number of subjects with clinically significant laboratory abnormalities (chemistry, hematology, and coagulation) were reported. Safety analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg and IVIg 1000 mg/kg Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    6
    5
    Units: subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Parts A, B, and C: Number of Subjects with Clinically Significant Abnormalities in Vital Signs

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    End point title
    		 Parts A, B, and C: Number of Subjects with Clinically Significant Abnormalities in Vital Signs [4]
    End point description
    Number of subjects with clinically significant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) were reported. Safety analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg and IVIg 1000 mg/kg Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    6
    5
    Units: subjects
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    No statistical analyses for this end point

    Primary: Parts A, B, and C: Number of Subjects with Clinically Significant Abnormalities in Electrocardiograms (ECGs)

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    End point title
    		 Parts A, B, and C: Number of Subjects with Clinically Significant Abnormalities in Electrocardiograms (ECGs) [5]
    End point description
    Number of subjects with clinically significant abnormalities in ECGs were reported. Safety analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg and IVIg 1000 mg/kg Part C: IVIg 1000 mg/kg and M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    6
    5
    Units: subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part C: Number of Subjects with Overall Platelet Response After M254 Administration Compared to IVIg

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    End point title
    		 Part C: Number of Subjects with Overall Platelet Response After M254 Administration Compared to IVIg [6]
    End point description
    Number of subjects with overall platelet response after M254 administration compared to IVIg were reported. Overall platelet response rate is defined as reaching the therapeutic platelet count. A therapeutic platelet count is defined as greater than or equal to (>=) 50 * 10^9/litre (L) and an increase from baseline of >=20 * 10^9/L. The full analysis set consisted of all subjects who were included in the safety set for whom at least 1 post-infusion pharmacodynamics (PD) assessment was completed. Here, N (number of subjects analysed) indicates number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    		 Part C: M254 120 mg/kg Part C: IVIg 1000 mg/kg
    Number of subjects analysed
    11
    10
    Units: subjects
    8
    9
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Maximum Observed Plasma Concentration (Cmax) of M254

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    End point title
    		 Parts A, B, and C: Maximum Observed Plasma Concentration (Cmax) of M254 [7]
    End point description
    Cmax is defined as the maximum observed plasma concentration of M254. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, 99999 signifies that as planned, the data was not collected for arms where total number of subjects for a treatment was lower than 3.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [7] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    11
    Units: micrograms per millilitre (mcg/mL)
        geometric mean (full range (min-max))
    2.55 (0.600 to 6.10)
    53.5 (51.5 to 55.3)
    193 (172 to 242)
    588 (532 to 664)
    1244 (1148 to 1351)
    2722 (2423 to 3099)
    5123 (3910 to 6316)
    99999 (99999 to 99999)
    1178 (728 to 1724)
    2794 (2480 to 3548)
    99999 (99999 to 99999)
    3464 (2341 to 6008)
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of M254

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    End point title
    		 Parts A, B, and C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of M254 [8]
    End point description
    Tmax is defined as the time to reach the maximum plasma concentration of M254. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [8] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    11
    Units: hours
        median (full range (min-max))
    338.68 (336.98 to 507.73)
    0.60 (0.60 to 1.10)
    0.45 (0.43 to 2.33)
    0.77 (0.77 to 1.03)
    1.23 (1.20 to 3.18)
    1.83 (1.70 to 2.63)
    2.62 (2.40 to 2.67)
    1.02 (0.87 to 1.17)
    1.48 (1.12 to 1.67)
    1.93 (1.67 to 2.07)
    2.74 (2.53 to 2.95)
    1.85 (1.60 to 2.13)
    No statistical analyses for this end point

    Secondary: Parts A and B, and C: Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of M254

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    End point title
    		 Parts A and B, and C: Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of M254 [9]
    End point description
    AUC (0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinite time of M254. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, 99999 signifies that the data could not be calculated due to insufficient data available for reliable parameter calculation (Part A: Placebo); and as planned, the data was not collected for arms where total number of subjects for a treatment was lower than 3 (Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg and Part B: M254 250 mg/kg and IVIg 1000 mg/kg).
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [9] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    11
    Units: h*micrograms per millilitre (h*mcg/mL)
        geometric mean (full range (min-max))
    99999 (99999 to 99999)
    18944 (12867 to 24589)
    75279 (68012 to 87057)
    211644 (201291 to 223299)
    604174 (521893 to 654506)
    1166585 (997104 to 1351535)
    2082296 (1568703 to 2620469)
    99999 (99999 to 99999)
    404424 (281920 to 527941)
    913565 (847526 to 1000004)
    99999 (99999 to 99999)
    1073227 (693431 to 1377293)
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of M254

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    End point title
    		 Parts A, B, and C: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of M254 [10]
    End point description
    AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of M254. AUC (0-last) is calculated by linear-linear trapezoidal summation. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, 99999 signifies that as planned, the data was not collected for arms where total number of subjects for a treatment was lower than 3.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    11
    Units: mcg*h/mL
        geometric mean (full range (min-max))
    489 (52.5 to 1441)
    11268 (9770 to 12701)
    40883 (36176 to 47809)
    112875 (105884 to 121740)
    282488 (251122 to 329379)
    661753 (630464 to 704177)
    1192832 (996669 to 1315203)
    99999 (99999 to 99999)
    279072 (159477 to 415464)
    590785 (546849 to 656664)
    99999 (99999 to 99999)
    708864 (475511 to 1041499)
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Apparent Terminal Phase Half-life (t1/2) of M254

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    End point title
    		 Parts A, B, and C: Apparent Terminal Phase Half-life (t1/2) of M254 [11]
    End point description
    t1/2 is defined as the time measured for the plasma concentration to decrease by 1 half to its original concentration of M254. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, 99999 signifies that the data could not be calculated due to insufficient data available for reliable parameter calculation (Part A: Placebo); and as planned, the data was not collected for arms where total number of subjects for a treatment was lower than 3 (Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg and Part B: M254 250 mg/kg and IVIg 1000 mg/kg).
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [11] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    7
    3
    3
    3
    3
    3
    3
    2
    5
    5
    2
    11
    Units: hours
        geometric mean (full range (min-max))
    99999 (99999 to 99999)
    379 (239 to 488)
    463 (412 to 520)
    481 (405 to 530)
    616 (565 to 679)
    588 (468 to 660)
    590 (493 to 762)
    99999 (99999 to 99999)
    475 (427 to 525)
    480 (399 to 595)
    99999 (99999 to 99999)
    410 (254 to 696)
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Volume of Distribution (Vz) of M254

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    End point title
    		 Parts A, B, and C: Volume of Distribution (Vz) of M254 [12]
    End point description
    Vz is defined as volume of distribution of M254 at terminal phase. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, N (number of subjects analysed) indicates number of subjects evaluable for this endpoint. Here, “99999" signifies that the data could not be calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [12] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    2
    4
    5
    1
    10
    Units: mL
        arithmetic mean (standard deviation)
    6825 ( 781 )
    6490 ( 790 )
    5986 ( 1870 )
    6975 ( 267 )
    5937 ( 847 )
    7475 ( 2124 )
    8679 ( 99999 )
    9367 ( 4634 )
    6916 ( 1223 )
    99999 ( 99999 )
    5997 ( 1887 )
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Clearance (CL) of M254

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    End point title
    		 Parts A, B, and C: Clearance (CL) of M254 [13]
    End point description
    CL is defined as clearance of M254, calculated as dose/AUC (0-infinity). PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, N (number of subjects analyzed) indicates number of subjects evaluable for this endpoint. Here, “99999" signifies that the data could not be calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [13] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    2
    4
    5
    1
    10
    Units: millilitre/hour
        arithmetic mean (standard deviation)
    13.7 ( 7.60 )
    9.69 ( 0.730 )
    8.49 ( 1.79 )
    7.87 ( 0.745 )
    7.16 ( 2.14 )
    9.16 ( 4.26 )
    15.6 ( 99999 )
    13.2 ( 5.33 )
    9.97 ( 1.70 )
    99999 ( 99999 )
    9.73 ( 1.72 )
    No statistical analyses for this end point

    Secondary: Parts A, B, and C: Mean Residence Time (MRT) of M254

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    End point title
    		 Parts A, B, and C: Mean Residence Time (MRT) of M254 [14]
    End point description
    Mean residence time is calculated as area under the first moment curve of M254. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, N (number of subjects analyzed) indicates number of subjects evaluable for this endpoint. Here, "99999" signifies that the data could not be calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [14] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    2
    4
    5
    1
    10
    Units: hours
        arithmetic mean (standard deviation)
    570 ( 190 )
    654 ( 75.9 )
    676 ( 107 )
    867 ( 79.8 )
    820 ( 163 )
    818 ( 189 )
    517 ( 99999 )
    661 ( 77.0 )
    653 ( 109 )
    99999 ( 99999 )
    584 ( 177 )
    No statistical analyses for this end point

    Secondary: Parts A and B, and C: Percentage of the Estimated Part for the Calculation of AUC0-inf (%AUCextra) of M254

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    End point title
    		 Parts A and B, and C: Percentage of the Estimated Part for the Calculation of AUC0-inf (%AUCextra) of M254 [15]
    End point description
    Percentage of the estimated part for the calculation of AUC0-inf (%AUCextra) of M254 were reported. PK data analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo with at least 4 evaluable data points adequate to create an evaluable plasma concentration profile. Here, N (number of subjects analyzed) indicates number of subjects evaluable for this endpoint. Here, "99999" signifies that the data could not be calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    Notes
    [15] - 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: As planned, results for Part B were collected separately for M254 and IVIg for each arm in Part B, and combined results were collected for Part C.
    End point values
    		 Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg and IV immunoglubulin (IVIg) 1000 mg/kg Part B: M254 60 mg/kg and IVIg 1000 mg/kg Part B: M254 120 mg/kg and IVIg 1000 mg/kg Part B: M254 250 mg/kg and IVIg 1000 mg/kg Part C: M254 120 mg/kg
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    2
    4
    5
    1
    10
    Units: percent
        arithmetic mean (standard deviation)
    39.6 ( 13.4 )
    45.6 ( 4.0 )
    46.4 ( 6.0 )
    53.1 ( 4.2 )
    43.0 ( 7.4 )
    42.4 ( 7.3 )
    27.2 ( 99999 )
    37.3 ( 5.8 )
    35.1 ( 5.5 )
    99999 ( 99999 )
    30.5 ( 10.2 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 29
    Adverse event reporting additional description
    The safety analysis set included all subjects who received at least 1 dose of M254 or IVIg or placebo.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Subjects received a single intravenous (IV) infusion of matching placebo on Day 1.

    Reporting group title
    Part A: M254 3 milligrams/kilogram (mg/kg)
    Reporting group description
    		 Subjects received a single IV infusion of M254 3 mg/kg on Day 1.

    Reporting group title
    Part A: M254 10 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 10 mg/kg on Day 1.

    Reporting group title
    Part A: M254 30 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 30 mg/kg on Day 1.

    Reporting group title
    Part A: M254 60 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 60 mg/kg on Day 1.

    Reporting group title
    Part A: M254 120 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 120 mg/kg on Day 1.

    Reporting group title
    Part A: M254 250 mg/kg
    Reporting group description
    		 Subjects received a single IV infusion of M254 250 mg/kg on Day 1.

    Reporting group title
    Part B: M254 20 mg/kg - M254 period
    Reporting group description
    		 Subjects with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 milligrams/kilogram (mg/kg) on Day 1.

    Reporting group title
    Part B: M254 20 mg/kg - IVIg period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IV immunoglubulin (IVIg) 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 60 mg/kg - M254 period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 60 mg/kg on Day 1.

    Reporting group title
    Part B: M254 60 mg/kg - IVIg period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 120 mg/kg - M254 period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1.

    Reporting group title
    Part B: M254 120 mg/kg - IVIg period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part B: M254 250 mg/kg - M254 period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 250 mg/kg on Day 1.

    Reporting group title
    Part B: M254 250 mg/kg - IVIg period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part C: M254 120 mg/kg and IVIg 1000 mg/kg - M254 period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1.

    Reporting group title
    Part C: M254 120 mg/kg and IVIg 1000 mg/kg - IVIg period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.

    Reporting group title
    Part C: IVIg 1000 mg/kg and M254 120 mg/kg - IVIg period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1.

    Reporting group title
    Part C: IVIg 1000 mg/kg and M254 120 mg/kg - M254 period
    Reporting group description
    		 Subjects with ITP received a single IV infusion of M254 120 mg/kg on Day 1.

    Serious adverse events
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg - M254 period Part B: M254 20 mg/kg - IVIg period Part B: M254 60 mg/kg - M254 period Part B: M254 60 mg/kg - IVIg period Part B: M254 120 mg/kg - M254 period Part B: M254 120 mg/kg - IVIg period Part B: M254 250 mg/kg - M254 period Part B: M254 250 mg/kg - IVIg period Part C: M254 120 mg/kg and IVIg 1000 mg/kg - M254 period Part C: M254 120 mg/kg and IVIg 1000 mg/kg - IVIg period Part C: IVIg 1000 mg/kg and M254 120 mg/kg - IVIg period Part C: IVIg 1000 mg/kg and M254 120 mg/kg - M254 period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: Placebo Part A: M254 3 milligrams/kilogram (mg/kg) Part A: M254 10 mg/kg Part A: M254 30 mg/kg Part A: M254 60 mg/kg Part A: M254 120 mg/kg Part A: M254 250 mg/kg Part B: M254 20 mg/kg - M254 period Part B: M254 20 mg/kg - IVIg period Part B: M254 60 mg/kg - M254 period Part B: M254 60 mg/kg - IVIg period Part B: M254 120 mg/kg - M254 period Part B: M254 120 mg/kg - IVIg period Part B: M254 250 mg/kg - M254 period Part B: M254 250 mg/kg - IVIg period Part C: M254 120 mg/kg and IVIg 1000 mg/kg - M254 period Part C: M254 120 mg/kg and IVIg 1000 mg/kg - IVIg period Part C: IVIg 1000 mg/kg and M254 120 mg/kg - IVIg period Part C: IVIg 1000 mg/kg and M254 120 mg/kg - M254 period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    0 / 3 (0.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    2 / 5 (40.00%)
    2 / 4 (50.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    2 / 5 (40.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Catheter Site Bruise
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter Site Haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter Site Related Reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Feeling Hot
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion Site Haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion Site Reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion Site Swelling
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Medical Device Site Irritation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vessel Puncture Site Bruise
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vessel Puncture Site Haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vessel Puncture Site Reaction
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasal Dryness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Platelet Count Decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion Related Reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Limb Injury
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Road Traffic Accident
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    3 / 7 (42.86%)
    3 / 3 (100.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    2 / 4 (50.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    4
    3
    0
    1
    0
    3
    3
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Faeces Soft
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    2 / 4 (50.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Contact
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry Skin
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin Irritation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bone Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 7 (57.14%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    5
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Iron Deficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vitamin B12 Deficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Part C (Group 2) and Part D was planned but not conducted based on sponsor decision to discontinue the study after completion of Part A, Part B, and Part C (Group 1). No safety concerns were identified and study was terminated for business reasons.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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