Trial Outcomes & Findings for Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients (NCT NCT03866577)
NCT ID: NCT03866577
Last Updated: 2025-05-28
Results Overview
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.
TERMINATED
PHASE1/PHASE2
50 participants
From Day 1 up to Day 29
2025-05-28
Participant Flow
Part C Group 2 and Part D of the study was not conducted as planned due to early study termination.
Participant milestones
| Measure |
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
3
|
3
|
3
|
3
|
3
|
2
|
5
|
5
|
2
|
6
|
5
|
|
Overall Study
COMPLETED
|
7
|
3
|
3
|
3
|
3
|
3
|
3
|
2
|
4
|
3
|
2
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A: Pooled Placebo
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Not qualified for IVIg infusion
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
Baseline characteristics by cohort
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg and IV Immunoglobulin (IVIg) 1000 mg/kg
n=2 Participants
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.
|
Part B: M254 60 mg/kg and IVIg 1000 mg/kg
n=5 Participants
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.
|
Part B: M254 120 mg/kg and IVIg 1000 mg/kg
n=5 Participants
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.
|
Part B: M254 250 mg/kg and IVIg 1000 mg/kg
n=2 Participants
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.
|
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg
n=6 Participants
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.
|
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg
n=5 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 7.64 • n=7 Participants
|
32 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
27 years
STANDARD_DEVIATION 1 • n=4 Participants
|
29 years
STANDARD_DEVIATION 7.81 • n=21 Participants
|
32.7 years
STANDARD_DEVIATION 15.53 • n=8 Participants
|
24.3 years
STANDARD_DEVIATION 4.51 • n=8 Participants
|
44 years
STANDARD_DEVIATION 4.24 • n=24 Participants
|
51.8 years
STANDARD_DEVIATION 11.45 • n=42 Participants
|
44 years
STANDARD_DEVIATION 12.94 • n=42 Participants
|
54.5 years
STANDARD_DEVIATION 13.44 • n=42 Participants
|
58 years
STANDARD_DEVIATION 14.48 • n=42 Participants
|
60 years
STANDARD_DEVIATION 12.63 • n=36 Participants
|
41.7 years
STANDARD_DEVIATION 15.98 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
26 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
45 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
Netherlands
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
27 Participants
n=36 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 29Population: Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=4 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
n=3 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
n=2 Participants
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part C (Group 1) : M254 120 mg/kg and IVIg 1000 mg/kg - M254 Period
n=6 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1.
|
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 29.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 29Population: Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=6 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 29Population: Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=6 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 29Population: Safety analysis set included all participants who received at least 1 dose of M254 or IVIg or placebo.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=6 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=11 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=10 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Maximum Observed Response of M254 (Rmax) on Platelet Count
|
62.4 10^9 cells per liter
Standard Deviation 20.1
|
136 10^9 cells per liter
Standard Deviation 70.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=11 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=10 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Change From Baseline in Rmax of M254 in Platelet Count
|
28.8 10^9 cells per liter
Standard Deviation 22.2
|
10.5 10^9 cells per liter
Standard Deviation 67.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (baseline) up to Day 14 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=11 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=10 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
3938 10^9 cells *hours per liter
Standard Deviation 3952
|
21199 10^9 cells *hours per liter
Standard Deviation 19349
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=11 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=10 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
5774 10^9 cells *hours per liter
Standard Deviation 9453
|
29985 10^9 cells *hours per liter
Standard Deviation 29265
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=11 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=10 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
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.
|
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.
|
Part B: M254 60 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Overall Platelet Response After M254 Administration Compared to IVIg
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=11 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Maximum Observed Plasma Concentration (Cmax) of M254
|
3.20 micrograms per milliliter (mcg/mL)
Interval 0.6 to 6.1
|
53.9 micrograms per milliliter (mcg/mL)
Interval 51.5 to 55.3
|
174 micrograms per milliliter (mcg/mL)
Interval 172.0 to 242.0
|
575 micrograms per milliliter (mcg/mL)
Interval 532.0 to 664.0
|
1240 micrograms per milliliter (mcg/mL)
Interval 1148.0 to 1351.0
|
2684 micrograms per milliliter (mcg/mL)
Interval 2423.0 to 3099.0
|
5444 micrograms per milliliter (mcg/mL)
Interval 3910.0 to 6316.0
|
431 micrograms per milliliter (mcg/mL)
Interval 383.0 to 479.0
|
1338 micrograms per milliliter (mcg/mL)
Interval 728.0 to 1724.0
|
2650 micrograms per milliliter (mcg/mL)
Interval 2480.0 to 3548.0
|
5624 micrograms per milliliter (mcg/mL)
Interval 4805.0 to 6444.0
|
3068 micrograms per milliliter (mcg/mL)
Interval 2341.0 to 6008.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=11 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of M254
|
338.68 hours
Interval 336.98 to 507.73
|
0.60 hours
Interval 0.6 to 1.1
|
0.45 hours
Interval 0.43 to 2.33
|
0.77 hours
Interval 0.77 to 1.03
|
1.23 hours
Interval 1.2 to 3.18
|
1.83 hours
Interval 1.7 to 2.63
|
2.62 hours
Interval 2.4 to 2.67
|
1.02 hours
Interval 0.87 to 1.17
|
1.48 hours
Interval 1.12 to 1.67
|
1.93 hours
Interval 1.67 to 2.07
|
2.74 hours
Interval 2.53 to 2.95
|
1.85 hours
Interval 1.6 to 2.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=1 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=10 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-Infinity]) of M254
|
NA micrograms*hour milliliter (mcg*h/mL)
'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.
|
21488 micrograms*hour milliliter (mcg*h/mL)
Interval 12867.0 to 24589.0
|
72050 micrograms*hour milliliter (mcg*h/mL)
Interval 68012.0 to 87057.0
|
210916 micrograms*hour milliliter (mcg*h/mL)
Interval 201291.0 to 223299.0
|
645641 micrograms*hour milliliter (mcg*h/mL)
Interval 521893.0 to 654506.0
|
1178098 micrograms*hour milliliter (mcg*h/mL)
Interval 997104.0 to 1351535.0
|
2196380 micrograms*hour milliliter (mcg*h/mL)
Interval 1568703.0 to 2620469.0
|
132265 micrograms*hour milliliter (mcg*h/mL)
Interval 109746.0 to 154785.0
|
423957 micrograms*hour milliliter (mcg*h/mL)
Interval 281920.0 to 527941.0
|
928888 micrograms*hour milliliter (mcg*h/mL)
Interval 847526.0 to 1000004.0
|
1839253 micrograms*hour milliliter (mcg*h/mL)
Interval 1839253.0 to 1839253.0
|
1112165 micrograms*hour milliliter (mcg*h/mL)
Interval 693431.0 to 1377293.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=2 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=11 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
593 mcg*h/mL
Interval 52.5 to 1441.0
|
11531 mcg*h/mL
Interval 9770.0 to 12701.0
|
39509 mcg*h/mL
Interval 36176.0 to 47809.0
|
111564 mcg*h/mL
Interval 105884.0 to 121740.0
|
272532 mcg*h/mL
Interval 251122.0 to 329379.0
|
652747 mcg*h/mL
Interval 630464.0 to 704177.0
|
1294774 mcg*h/mL
Interval 996669.0 to 1315203.0
|
96329 mcg*h/mL
Interval 79956.0 to 112703.0
|
287567 mcg*h/mL
Interval 159477.0 to 415464.0
|
588913 mcg*h/mL
Interval 546849.0 to 656664.0
|
1182466 mcg*h/mL
Interval 1136975.0 to 1227957.0
|
700805 mcg*h/mL
Interval 700805.0 to 1041499.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=7 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=1 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=10 Participants
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Apparent Terminal Phase Half-life (t1/2) of M254
|
NA hours
'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.
|
466 hours
Interval 239.0 to 488.0
|
463 hours
Interval 412.0 to 520.0
|
517 hours
Interval 405.0 to 530.0
|
609 hours
Interval 565.0 to 679.0
|
659 hours
Interval 468.0 to 660.0
|
548 hours
Interval 493.0 to 762.0
|
387 hours
Interval 383.0 to 390.0
|
478 hours
Interval 427.0 to 525.0
|
437 hours
Interval 399.0 to 595.0
|
467 hours
Interval 467.0 to 467.0
|
391 hours
Interval 254.0 to 696.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=3 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=2 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=4 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=1 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=10 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Volume of Distribution (Vz) of M254
|
6481 milliliter (mL)
Interval 6274.0 to 7719.0
|
6129 milliliter (mL)
Interval 5944.0 to 7396.0
|
5447 milliliter (mL)
Interval 4445.0 to 8066.0
|
7105 milliliter (mL)
Interval 6668.0 to 7151.0
|
6383 milliliter (mL)
Interval 4960.0 to 6468.0
|
6419 milliliter (mL)
Interval 6087.0 to 9920.0
|
8679 milliliter (mL)
Interval 7487.0 to 9871.0
|
5259 milliliter (mL)
Interval 5197.0 to 5321.0
|
7258 milliliter (mL)
Interval 4907.0 to 7967.0
|
9623 milliliter (mL)
Interval 9623.0 to 9623.0
|
6059 milliliter (mL)
Interval 2485.0 to 8707.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=3 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=2 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=4 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=1 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=10 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Clearance (CL) of M254
|
9.63 milliliters per hour (mL/h)
Interval 8.92 to 22.4
|
9.85 milliliters per hour (mL/h)
Interval 8.89 to 10.3
|
7.62 milliliters per hour (mL/h)
Interval 7.3 to 10.5
|
7.59 milliliters per hour (mL/h)
Interval 7.3 to 8.71
|
6.79 milliliters per hour (mL/h)
Interval 5.22 to 9.46
|
7.69 milliliters per hour (mL/h)
Interval 5.84 to 14.0
|
15.6 milliliters per hour (mL/h)
Interval 13.3 to 17.9
|
12.0 milliliters per hour (mL/h)
Interval 8.64 to 20.2
|
9.69 milliliters per hour (mL/h)
Interval 7.79 to 11.7
|
14.3 milliliters per hour (mL/h)
Interval 14.3 to 14.3
|
10.1 milliliters per hour (mL/h)
Interval 6.77 to 12.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=3 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=2 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=4 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=1 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=10 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Mean Residence Time (MRT) of M254
|
570 hours
Standard Deviation 190
|
654 hours
Standard Deviation 75.9
|
676 hours
Standard Deviation 107
|
867 hours
Standard Deviation 79.8
|
820 hours
Standard Deviation 163
|
818 hours
Standard Deviation 189
|
517 hours
Standard Deviation 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.
|
661 hours
Standard Deviation 77.0
|
653 hours
Standard Deviation 109
|
610 hours
Standard Deviation 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.
|
584 hours
Standard Deviation 177
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (baseline) up to Day 29 post dosePopulation: 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.
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.
Outcome measures
| Measure |
Part A: Pooled Placebo
n=3 Participants
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 Participants
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 Participants
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=2 Participants
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=4 Participants
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=5 Participants
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=1 Participants
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=10 Participants
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A, B, and C: Percentage of the Estimated Part for the Calculation of AUC(0-infinity) (%AUCextra) of M254
|
46.3 Percentage of AUC(0-infinity)
Interval 24.1 to 48.3
|
45.1 Percentage of AUC(0-infinity)
Interval 41.9 to 49.8
|
49.8 Percentage of AUC(0-infinity)
Interval 39.5 to 50.0
|
51.9 Percentage of AUC(0-infinity)
Interval 49.7 to 57.8
|
46.5 Percentage of AUC(0-infinity)
Interval 34.5 to 47.9
|
40.1 Percentage of AUC(0-infinity)
Interval 36.5 to 50.6
|
27.2 Percentage of AUC(0-infinity)
Interval 27.1 to 27.2
|
37.0 Percentage of AUC(0-infinity)
Interval 31.9 to 43.4
|
31.9 Percentage of AUC(0-infinity)
Interval 29.9 to 41.1
|
33.2 Percentage of AUC(0-infinity)
Interval 33.2 to 33.2
|
27.6 Percentage of AUC(0-infinity)
Interval 17.5 to 50.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Pooled 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 (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - M254 Period
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - IVIg Period
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - IVIg Period
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - M254 Period
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Pooled Placebo
n=7 participants at risk
All healthy participants of Part A received a single intravenous (IV) infusion of matching placebo on Day 1.
|
Part A: M254 3 Milligrams/Kilogram (mg/kg)
n=3 participants at risk
Healthy participants received a single IV infusion of M254 3 mg/kg on Day 1.
|
Part A: M254 10 mg/kg
n=3 participants at risk
Healthy participants received a single IV infusion of M254 10 mg/kg on Day 1.
|
Part A: M254 30 mg/kg
n=3 participants at risk
Healthy participants received a single IV infusion of M254 30 mg/kg on Day 1.
|
Part A: M254 60 mg/kg
n=3 participants at risk
Healthy participants received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part A: M254 120 mg/kg
n=3 participants at risk
Healthy participants received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part A: M254 250 mg/kg
n=3 participants at risk
Healthy participants received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - M254 Period
n=2 participants at risk
Participants with immune thrombocytopenia purpura (ITP) received a single intravenous (IV) infusion of M254 20 mg/kg on Day 1.
|
Part B: M254 20 mg/kg - IVIg Period
n=2 participants at risk
Participants with ITP received a single IV infusion of IV immunoglobulin (IVIg) 1000 mg/kg on Day 29.
|
Part B: M254 60 mg/kg - M254 Period
n=5 participants at risk
Participants with ITP received a single IV infusion of M254 60 mg/kg on Day 1.
|
Part B: M254 60 mg/kg - IVIg Period
n=4 participants at risk
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 120 mg/kg - M254 Period
n=5 participants at risk
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part B: M254 120 mg/kg - IVIg Period
n=3 participants at risk
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part B: M254 250 mg/kg - M254 Period
n=2 participants at risk
Participants with ITP received a single IV infusion of M254 250 mg/kg on Day 1.
|
Part B: M254 250 mg/kg - IVIg Period
n=2 participants at risk
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - M254 Period
n=6 participants at risk
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 1.
|
Part C (Group 1): M254 120 mg/kg and IVIg 1000 mg/kg - IVIg Period
n=5 participants at risk
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 29.
|
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - IVIg Period
n=5 participants at risk
Participants with ITP received a single IV infusion of IVIg 1000 mg/kg on Day 1.
|
Part C (Group 1): IVIg 1000 mg/kg and M254 120 mg/kg - M254 Period
n=5 participants at risk
Participants with ITP received a single IV infusion of M254 120 mg/kg on Day 29.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
16.7%
1/6 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 4 • From Day 1 up to Day 29
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.
|
100.0%
3/3 • Number of events 3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
66.7%
2/3 • Number of events 3 • From Day 1 up to Day 29
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.
|
100.0%
3/3 • Number of events 3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
50.0%
2/4 • Number of events 2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
25.0%
1/4 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Catheter Site Related Reaction
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 4 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
25.0%
1/4 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
25.0%
1/4 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
50.0%
2/4 • Number of events 3 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Catheter Site Bruise
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Catheter Site Haematoma
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Feeling Hot
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
25.0%
1/4 • Number of events 2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Infusion Site Haematoma
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Infusion Site Reaction
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Infusion Site Swelling
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Medical Device Site Irritation
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
25.0%
1/4 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Vessel Puncture Site Bruise
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
General disorders
Vessel Puncture Site Reaction
|
14.3%
1/7 • Number of events 2 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Infections and infestations
Nasopharyngitis
|
57.1%
4/7 • Number of events 5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 3 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
50.0%
1/2 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
25.0%
1/4 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
14.3%
1/7 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
33.3%
1/3 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/4 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
0.00%
0/3 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/2 • From Day 1 up to Day 29
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.
|
0.00%
0/6 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
20.0%
1/5 • Number of events 1 • From Day 1 up to Day 29
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.
|
0.00%
0/5 • From Day 1 up to Day 29
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.
|
Additional Information
Senior Director Clinical Development Head Rheumatology
Momenta Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER