Safety and Tolerability of M254 in Healthy Volunteers and... | NCT03866577 | Trialant
NCT03866577
Sponsor
Momenta Pharmaceuticals, Inc.
Status
Terminated
Last Update Posted
May 28, 2025Actual
Enrollment
50Actual
Phase
Phase 1Phase 2
Conditions
Immune Thrombocytopenic Purpura (ITP)
Interventions
Biological: M254
Placebo
Intravenous immunoglobulin (IVIg)
Countries
United States
Belgium
Hungary
Italy
Netherlands
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT03866577
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108979
Secondary IDs
ID
Type
Description
Link
2018-003534-32
EudraCT Number
MOM-M254-001
Other Identifier
Momenta Pharmaceuticals, Inc.
Brief Title
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
Official Title
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
Acronym
Not provided
Organization
Momenta Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was terminated based on Sponsor decision.
Expanded Access Info
No
Start Date
Dec 21, 2018Actual
Primary Completion Date
Jun 9, 2021Actual
Completion Date
Jun 9, 2021Actual
First Submitted Date
Feb 12, 2019
First Submission Date that Met QC Criteria
Mar 5, 2019
First Posted Date
Mar 7, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2024
Results First Submitted that Met QC Criteria
Jun 3, 2024
Results First Posted Date
Jul 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 6, 2022
Certification/Extension First Submitted that Passed QC Review
Jun 6, 2022
Certification/Extension First Posted Date
Jun 8, 2022Actual
Last Update Submitted Date
May 26, 2025
Last Update Posted Date
May 28, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Momenta Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.
Detailed Description
The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.
Conditions Module
Conditions
Immune Thrombocytopenic Purpura (ITP)
Keywords
Immune thrombocytopenic purpura
Healthy subjects
M254
Intravenous immunoglobulin (IVIg)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A
Experimental
Healthy volunteers will receive a single ascending dose of M254 or placebo
Biological: Biological: M254
Drug: Placebo
Part B
Experimental
Immune thrombocytopenic purpura (ITP) patients will receive a single ascending dose of M254 followed by IVIg
Biological: Biological: M254
Biological: Intravenous immunoglobulin (IVIg)
Part C
Experimental
ITP patients will receive a single dose of M254 or IVIg, followed by a single dose of the other drug approximately 28 days later
Biological: Biological: M254
Biological: Intravenous immunoglobulin (IVIg)
Part D
Experimental
ITP patients will receive repeated doses of M254
Biological: Biological: M254
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Biological: M254
Biological
M254 administered as intravenous infusion
Part A
Part B
Part C
Part D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE was defined as any event not present prior to administration of the study drug or any event already present that worsened in either severity or frequency following exposure to the study drug. Severity was 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. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. For Parts B and C, treatment period wise AE data were presented.
From Day 1 up to Day 29
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Number of participants with clinically significant laboratory abnormalities (chemistry, hematology, urinalysis and coagulation) were reported. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A.
From Day 1 up to Day 29
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant abnormalities in vital signs (blood pressure [systolic blood pressure {SBP} and diastolic blood pressure {DBP}], pulse rate, respiratory rate, and body temperature) were reported. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A.
From Day 1 up to Day 29
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
Secondary Outcomes
Measure
Description
Time Frame
Part C: Number of Participants With Overall Platelet Response After M254 Administration Compared to IVIg
Number of participants 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 cells/liter (L) and an increase from baseline of >=20*10^9 cells/L. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) the participants received.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Criteria for Healthy Volunteers: Subject must be between the ages of 18 and 55 years; healthy as indicated by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram, and all abnormal findings are assessed as not clinically significant by the Investigator; not pregnant or breastfeeding; and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Key Criteria for Immune Thrombocytopenic Purpura (ITP) Patients: Patient must be aged ≥18 years and diagnosed with ITP at least 3 months prior to screening, stable maintenance therapy for at least 4 weeks prior to the first study visit, not pregnant or breastfeeding, and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Momenta General Queries
Momenta Pharmaceuticals, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Southern California
Los Angeles
California
90089
United States
Oncology Institute of Hope and Innovation
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Part C Group 2 and Part D of the study was not conducted as planned due to early study termination.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
FG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 28, 2020
Jun 3, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Germany
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Part A: Double (Subject, Investigator);
Part B, C, and D: Open Label Investigations
Who Masked
Not provided
Placebo
Drug
Placebo administered as intravenous infusion
Part A
Intravenous immunoglobulin (IVIg)
Biological
IVIg administered as intravenous infusion
Part B
Part C
Number of participants with clinically significant abnormalities in ECGs were reported. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A.
From Day 1 up to Day 29
Part C: Maximum Observed Response of M254 (Rmax) on Platelet Count
Rmax is defined as the maximum observed response of M254 on platelet count. Baseline was the pre-dose sample. Data was planned to be collected and analyzed Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) which the participants received.
Predose (baseline) up to Day 29 post dose
Part C: Change From Baseline in Rmax of M254 in Platelet Count
Change from baseline in Rmax of M254 in platelet count was reported. Rmax is defined as the maximum observed response of M254. Baseline was the predose sample. Therapeutic platelet count was defined as >=50*10^9 cells/L. Platelet response of >=20*10^9 cells/L was considered as increase from baseline. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) which the participants received.
Predose (baseline) up to Day 29 post dose
Part C: Area Under Effect Curve of the Change From Baseline in Platelet Count From Day 0 to Day 14 (AUEC[0-Day 14]) of M254
AUEC(0-Day 14) is defined as the area under effect curve of the change from baseline in platelet count from Day 0 to Day 14 of M254. Baseline was the predose sample. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) which the participants received.
Predose (baseline) up to Day 14 post dose
Part C: Area Under Effect Curve of the Change From Baseline in Platelet Count From Day 0 to Day 28 (AUEC[0-Day 28]) of M254
AUEC(0-Day 28) is defined as the area under effect curve of the change from baseline in platelet count from Day 0 to Day 28 of M254. Baseline was the predose sample. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) the participants received.
Predose (baseline) up to Day 29 post dose
Up to Day 29
Parts A, B, and C: Maximum Observed Plasma Concentration (Cmax) of M254
Cmax is defined as the maximum observed plasma concentration of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of M254
Tmax is defined as the time to reach the maximum observed plasma concentration of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-Infinity]) of M254
AUC(0-Infinity) is defined as area under the plasma concentration-time curve from time 0 to infinite time of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
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
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. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Apparent Terminal Phase Half-life (t1/2) of M254
t1/2 is defined as the time measured for the plasma concentration to decrease by 1 half to its original concentration of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Volume of Distribution (Vz) of M254
Vz is defined as volume of distribution of M254 at terminal phase. Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Clearance (CL) of M254
CL is defined as clearance of M254, calculated as dose/AUC(0-infinity). Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Mean Residence Time (MRT) of M254
Mean residence time is the average time that drug dose remained in the body. Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Predose (baseline) up to Day 29 post dose
Parts A, B, and C: Percentage of the Estimated Part for the Calculation of AUC(0-infinity) (%AUCextra) of M254
Percentage of the estimated part for the calculation of AUC(0-infinity) (%AUCextra) of M254 were reported. Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
47014
Italy
Azienda Unita Sanitaria Locale di Ravenna
Ravenna
48100
Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia
42123
Italy
Policlinico Universitario Agostino Gemelli
Roma
168
Italy
Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-
San Giovanni Rotondo
71013
Italy
Universitair Medisch Centrum Groningen
Groningen
9713 GZ
Netherlands
PRA Health Sciences
Groningen
NZ 9728
Netherlands
Silesian Healthy Blood Clinic
Chorzów
41 503
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin
20-081
Poland
Szpital Wojewodzki w Opolu
Opole
45-061
Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW w Poznaniu im prof Ludwika Bierkowskiego
Poznan
60-631
Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw
50 367
Poland
Hosp Univ Vall D Hebron
Barcelona
08035
Spain
Hosp. Univ. de Burgos
Burgos
09003
Spain
Hosp. Regional. Carlos Haya
Málaga
29010
Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia
30008
Spain
Hosp Clinico Univ de Salamanca
Salamanca
37007
Spain
Hosp. Univ. Dr. Peset
Valencia
46017
Spain
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
FG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
FG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
FG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
FG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
FG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
FG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
FG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
FG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
FG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
FG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
FG012
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg
Participants 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.
FG0007 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0072 subjects
FG0085 subjects
FG0095 subjects
FG0102 subjects
FG0116 subjects
FG0125 subjects
COMPLETED
FG0007 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0072 subjects
FG0084 subjects
FG0093 subjects
FG0102 subjects
FG0115 subjects
FG0125 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not qualified for IVIg infusion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
BG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
BG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
BG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
BG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
BG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
BG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
BG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
BG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
BG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
BG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
BG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
BG012
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg
Participants 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.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0013
BG0023
BG0033
BG0043
BG0053
BG0063
BG0072
BG0085
BG0095
BG0102
BG0116
BG0125
BG01350
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00032.9± 10.9
BG00131.3± 7.64
BG00232± 13.75
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Belgium
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE was defined as any event not present prior to administration of the study drug or any event already present that worsened in either severity or frequency following exposure to the study drug. Severity was 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. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. For Parts B and C, treatment period wise AE data were presented.
Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
Posted
Count of Participants
Participants
From Day 1 up to Day 29
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg - M254 Period
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
OG008
Part B: M254 20 mg/kg - IVIg Period
Units
Counts
Participants
OG0007
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0023
OG003
Primary
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Number of participants with clinically significant laboratory abnormalities (chemistry, hematology, urinalysis and coagulation) were reported. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A.
Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
Posted
Count of Participants
Participants
From Day 1 up to Day 29
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Part A: M254 30 mg/kg
Primary
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant abnormalities in vital signs (blood pressure [systolic blood pressure {SBP} and diastolic blood pressure {DBP}], pulse rate, respiratory rate, and body temperature) were reported. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A.
Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
Posted
Count of Participants
Participants
From Day 1 up to Day 29
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Part A: M254 30 mg/kg
Primary
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
Number of participants with clinically significant abnormalities in ECGs were reported. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A.
Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
Posted
Count of Participants
Participants
From Day 1 up to Day 29
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
Primary
Part C: Maximum Observed Response of M254 (Rmax) on Platelet Count
Rmax is defined as the maximum observed response of M254 on platelet count. Baseline was the pre-dose sample. Data was planned to be collected and analyzed Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) which the participants received.
The full analysis set consisted of all participants who received at least 1 dose of M254 or IVIg or placebo and for whom at least 1 post-infusion pharmacodynamics (PD) assessment was completed. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
10^9 cells per liter
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part C (Group 1): M254 120 mg/kg - M254 Period (Pooled)
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 and 29.
OG001
Part C (Group 1): IVIg 1000 mg/kg - IVIg Period (Pooled)
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Days 1 and 29.
Units
Counts
Primary
Part C: Change From Baseline in Rmax of M254 in Platelet Count
Change from baseline in Rmax of M254 in platelet count was reported. Rmax is defined as the maximum observed response of M254. Baseline was the predose sample. Therapeutic platelet count was defined as >=50*10^9 cells/L. Platelet response of >=20*10^9 cells/L was considered as increase from baseline. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) which the participants received.
The full analysis set consisted of all participants who received at least 1 dose of M254 or IVIg or placebo and for whom at least 1 post-infusion PD assessment was completed. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
10^9 cells per liter
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part C (Group 1): M254 120 mg/kg - M254 Period (Pooled)
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 and 29.
OG001
Part C (Group 1): IVIg 1000 mg/kg - IVIg Period (Pooled)
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Days 1 and 29.
Primary
Part C: Area Under Effect Curve of the Change From Baseline in Platelet Count From Day 0 to Day 14 (AUEC[0-Day 14]) of M254
AUEC(0-Day 14) is defined as the area under effect curve of the change from baseline in platelet count from Day 0 to Day 14 of M254. Baseline was the predose sample. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) which the participants received.
The full analysis set consisted of all participants who received at least 1 dose of M254 or IVIg or placebo and for whom at least 1 post-infusion PD assessment was completed. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
10^9 cells *hours per liter
Predose (baseline) up to Day 14 post dose
ID
Title
Description
OG000
Part C (Group 1): M254 120 mg/kg - M254 Period (Pooled)
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 and 29.
OG001
Part C (Group 1): IVIg 1000 mg/kg - IVIg Period (Pooled)
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Days 1 and 29.
Primary
Part C: Area Under Effect Curve of the Change From Baseline in Platelet Count From Day 0 to Day 28 (AUEC[0-Day 28]) of M254
AUEC(0-Day 28) is defined as the area under effect curve of the change from baseline in platelet count from Day 0 to Day 28 of M254. Baseline was the predose sample. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) the participants received.
The full analysis set consisted of all participants who received at least 1 dose of M254 or IVIg or placebo and for whom at least 1 post-infusion PD assessment was completed. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
10^9 cells *hours per liter
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part C (Group 1): M254 120 mg/kg - M254 Period (Pooled)
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 and 29.
OG001
Part C (Group 1): IVIg 1000 mg/kg - IVIg Period (Pooled)
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Days 1 and 29.
Secondary
Part C: Number of Participants With Overall Platelet Response After M254 Administration Compared to IVIg
Number of participants 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 cells/liter (L) and an increase from baseline of >=20*10^9 cells/L. Data was planned to be collected and analyzed for Part C only. For Part C, data were collected and analyzed on the pooled population per the study drug (M254 120 mg/kg and IVIg 1000 mg/kg) the participants received.
The full analysis set consisted of all participants who were included in the safety set for whom at least 1 post-infusion PD assessment was completed. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to Day 29
ID
Title
Description
OG000
Part C (Group 1) : M254 120 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 and 29.
OG001
Part C (Group 1): IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Days 1 and 29.
Secondary
Parts A, B, and C: Maximum Observed Plasma Concentration (Cmax) of M254
Cmax is defined as the maximum observed plasma concentration of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
Pharmacokinetic (PK) data analysis set included all randomized participants 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 of M254.
Posted
Median
Full Range
micrograms per milliliter (mcg/mL)
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
Secondary
Parts A, B, and C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of M254
Tmax is defined as the time to reach the maximum observed plasma concentration of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254.
Posted
Median
Full Range
hours
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Secondary
Parts A, B, and C: Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-Infinity]) of M254
AUC(0-Infinity) is defined as area under the plasma concentration-time curve from time 0 to infinite time of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Median
Full Range
micrograms*hour milliliter (mcg*h/mL)
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
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
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. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254.
Posted
Median
Full Range
mcg*h/mL
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Secondary
Parts A, B, and C: Apparent Terminal Phase Half-life (t1/2) of M254
t1/2 is defined as the time measured for the plasma concentration to decrease by 1 half to its original concentration of M254. Baseline was the predose sample. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Median
Full Range
hours
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
OG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
Secondary
Parts A, B, and C: Volume of Distribution (Vz) of M254
Vz is defined as volume of distribution of M254 at terminal phase. Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Median
Full Range
milliliter (mL)
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG001
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG002
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
Secondary
Parts A, B, and C: Clearance (CL) of M254
CL is defined as clearance of M254, calculated as dose/AUC(0-infinity). Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Median
Full Range
milliliters per hour (mL/h)
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG001
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG002
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
Secondary
Parts A, B, and C: Mean Residence Time (MRT) of M254
Mean residence time is the average time that drug dose remained in the body. Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hours
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG001
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG002
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
Secondary
Parts A, B, and C: Percentage of the Estimated Part for the Calculation of AUC(0-infinity) (%AUCextra) of M254
Percentage of the estimated part for the calculation of AUC(0-infinity) (%AUCextra) of M254 were reported. Baseline was the predose sample. Data for this outcome measure was not planned for pooled placebo arm in Part A and thus no data was presented for placebo arm in Part A. In Part C, combined data of both arms of Group 1 is presented as planned.
PK data analysis set included all randomized participants 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 of M254. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
Posted
Median
Full Range
Percentage of AUC(0-infinity)
Predose (baseline) up to Day 29 post dose
ID
Title
Description
OG000
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
OG001
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG002
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
Time Frame
From Day 1 up to Day 29
Description
The safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo. Data was planned to be collected and analyzed on pooled population of participants who received placebo in Part A. For Parts B and C, treatment period wise AE data were presented.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
0
7
0
7
6
7
EG001
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
0
3
0
3
3
3
EG002
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
0
3
0
3
3
3
EG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
0
3
0
3
3
3
EG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
0
3
0
3
0
3
EG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
0
3
0
3
3
3
EG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
0
3
0
3
3
3
EG007
Part B: M254 20 mg/kg - M254 Period
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
0
2
0
2
1
2
EG008
Part B: M254 20 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
0
2
0
2
0
2
EG009
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
0
5
0
5
2
5
EG010
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
0
4
0
4
2
4
EG011
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
0
5
0
5
1
5
EG012
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
0
3
0
3
1
3
EG013
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
0
2
0
2
0
2
EG014
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
0
2
0
2
0
2
EG015
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
0
6
0
6
1
6
EG016
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
0
5
0
5
0
5
EG017
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1.
0
5
0
5
2
5
EG018
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 29.
0
5
0
5
2
5
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected5 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected2 at risk
EG0140 events0 affected2 at risk
EG0150 events0 affected6 at risk
EG0160 events0 affected5 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected5 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Faeces Soft
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0003 events3 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter Site Bruise
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter Site Haematoma
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter Site Related Reaction
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Chills
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Feeling Hot
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Site Haematoma
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Site Reaction
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Site Swelling
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Medical Device Site Irritation
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vessel Puncture Site Bruise
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vessel Puncture Site Haematoma
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vessel Puncture Site Reaction
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0005 events4 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vitamin B12 Deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0004 events3 affected7 at risk
EG0013 events3 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Part C (Group 2) and Part D were 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.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The results of this study may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director Clinical Development Head Rheumatology
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
OG009
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
OG010
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
OG011
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
OG012
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
OG013
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
OG014
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
OG015
Part C (Group 1) : M254 120 mg/kg and IVIg 1000 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
OG016
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
OG017
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1.
OG018
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 29.
3
OG0043
OG0053
OG0063
OG0072
OG0082
OG0095
OG0104
OG0115
OG0123
OG0132
OG0142
OG0156
OG0165
OG0175
OG0185
3
OG0040
OG0053
OG0063
OG0071
OG0080
OG0092
OG0102
OG0111
OG0121
OG0130
OG0140
OG0151
OG0160
OG0172
OG0182
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG012
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg
Participants 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.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0102
OG0116
OG0125
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG012
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg
Participants 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.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0102
OG0116
OG0125
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG012
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg
Participants 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.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0102
OG0116
OG0125
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG00062.4± 20.1
OG001136± 70.0
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG00028.8± 22.2
OG00110.5± 67.3
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG0003938± 3952
OG00121199± 19349
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG0005774± 9453
OG00129985± 29265
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG0008
OG0019
OG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0102
OG01111
Title
Denominators
Categories
Title
Measurements
OG0003.20(0.600 to 6.10)
OG00153.9(51.5 to 55.3)
OG002174(172 to 242)
OG003575(532 to 664)
OG0041240(1148 to 1351)
OG0052684(2423 to 3099)
OG0065444(3910 to 6316)
OG007431(383 to 479)
OG0081338(728 to 1724)
OG0092650(2480 to 3548)
OG0105624(4805 to 6444)
OG0113068(2341 to 6008)
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0102
OG01111
Title
Denominators
Categories
Title
Measurements
OG000338.68(336.98 to 507.73)
OG0010.60(0.60 to 1.10)
OG0020.45(0.43 to 2.33)
OG0030.77(0.77 to 1.03)
OG0041.23(1.20 to 3.18)
OG0051.83(1.70 to 2.63)
OG0062.62(2.40 to 2.67)
OG0071.02(0.87 to 1.17)
OG0081.48(1.12 to 1.67)
OG0091.93(1.67 to 2.07)
OG0102.74(2.53 to 2.95)
OG0111.85(1.60 to 2.13)
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0101
OG01110
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)'NA' signifies that the median and full range (lower and upper limits) data could not be calculated due to insufficient data available for reliable parameter calculation.
OG00121488(12867 to 24589)
OG00272050(68012 to 87057)
OG003210916(201291 to 223299)
OG004645641(521893 to 654506)
OG0051178098(997104 to 1351535)
OG0062196380(1568703 to 2620469)
OG007132265(109746 to 154785)
OG008423957(281920 to 527941)
OG009928888(847526 to 1000004)
OG0101839253(1839253 to 1839253)
OG0111112165(693431 to 1377293)
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
OG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0102
OG01111
Title
Denominators
Categories
Title
Measurements
OG000593(52.5 to 1441)
OG00111531(9770 to 12701)
OG00239509(36176 to 47809)
OG003111564(105884 to 121740)
OG004272532(251122 to 329379)
OG005652747(630464 to 704177)
OG0061294774(996669 to 1315203)
OG00796329(79956 to 112703)
OG008287567(159477 to 415464)
OG009588913(546849 to 656664)
OG0101182466(1136975 to 1227957)
OG011700805(700805 to 1041499)
OG003
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
OG004
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG005
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG006
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG007
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG008
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG011
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0072
OG0085
OG0095
OG0101
OG01110
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)'NA' signifies that the median and full range (lower and upper limits) data could not be calculated due to insufficient data available for reliable parameter calculation.
OG001466(239 to 488)
OG002463(412 to 520)
OG003517(405 to 530)
OG004609(565 to 679)
OG005659(468 to 660)
OG006548(493 to 762)
OG007387(383 to 390)
OG008478(427 to 525)
OG009437(399 to 595)
OG010467(467 to 467)
OG011391(254 to 696)
OG003
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG004
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG005
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG006
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG007
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG008
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0062
OG0074
OG0085
OG0091
OG01010
Title
Denominators
Categories
Title
Measurements
OG0006481(6274 to 7719)
OG0016129(5944 to 7396)
OG0025447(4445 to 8066)
OG0037105(6668 to 7151)
OG0046383(4960 to 6468)
OG0056419(6087 to 9920)
OG0068679(7487 to 9871)
OG0075259(5197 to 5321)
OG0087258(4907 to 7967)
OG0099623(9623 to 9623)
OG0106059(2485 to 8707)
OG003
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG004
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG005
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG006
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG007
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG008
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0062
OG0074
OG0085
OG0091
OG01010
Title
Denominators
Categories
Title
Measurements
OG0009.63(8.92 to 22.4)
OG0019.85(8.89 to 10.3)
OG0027.62(7.30 to 10.5)
OG0037.59(7.30 to 8.71)
OG0046.79(5.22 to 9.46)
OG0057.69(5.84 to 14.0)
OG00615.6(13.3 to 17.9)
OG00712.0(8.64 to 20.2)
OG0089.69(7.79 to 11.7)
OG00914.3(14.3 to 14.3)
OG01010.1(6.77 to 12.5)
OG003
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG004
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG005
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG006
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG007
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG008
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0062
OG0074
OG0085
OG0091
OG01010
Title
Denominators
Categories
Title
Measurements
OG000570± 190
OG001654± 75.9
OG002676± 107
OG003867± 79.8
OG004820± 163
OG005818± 189
OG006517± NA'NA' signifies that the standard deviation was not calculated as planned when the total number of participants analyzed for a treatment was lower than 3.
OG007661± 77.0
OG008653± 109
OG009610± NA'NA' signifies that the standard deviation was not calculated as planned when the total number of participants analyzed for a treatment was lower than 3.
OG010584± 177
OG003
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
OG004
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
OG005
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
OG006
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
Participants 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.
OG007
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG008
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG009
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
Participants 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.
OG010
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
Participants with ITP received a single IV infusion of M254 120 mg/kg on Days 1 or 29 and single IV infusion of IVIg 1000 mg/kg on Days 1 or 29.