Trial Outcomes & Findings for SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease. (NCT NCT02036645)
NCT ID: NCT02036645
Last Updated: 2019-06-03
Results Overview
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
77 participants
Primary outcome timeframe
4 months SAD; 7 months MAD
Results posted on
2019-06-03
Participant Flow
261 screening visits in 193 individuals were required to randomize 45 subjects into 6 Single Ascending Dose (SAD) cohorts and 32 subjects into 4 Multiple Ascending Dose (MAD) cohorts.
Due to population (mild to moderate Alzheimer's disease) and duration (6 or 9 months) per cohort, rescreening was permitted. SAD had 128 screeings in105 subjects (23 rescreens); MAD had 133 screenings in 88 subjects, (22 rescreens from SAD and 23 rescreens from MAD). Note: 11 of 32 randomized MAD subjects had previously completed a SAD cohort.
Participant milestones
| Measure |
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
|
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SAD Cohorts : Study Part 1
STARTED
|
12
|
3
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohorts : Study Part 1
COMPLETED
|
12
|
3
|
6
|
5
|
6
|
6
|
5
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohorts : Study Part 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
MAD Cohorts: Study Part 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
6
|
6
|
6
|
6
|
|
MAD Cohorts: Study Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
6
|
6
|
6
|
6
|
|
MAD Cohorts: Study Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
|
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SAD Cohorts : Study Part 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohorts : Study Part 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Baseline characteristics by cohort
| Measure |
Placebo: SAD
n=12 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=3 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC: SAD
n=6 Participants
Medi1814 100 mg SC: CAD cohort 6
|
Placebo: MAD
n=8 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi 1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
n=6 Participants
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
n=6 Participants
Medi1814 200 mg SC: MAD cohort 10
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
74.0 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 1.94 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 6.10 • n=4 Participants
|
71.8 years
STANDARD_DEVIATION 5.15 • n=21 Participants
|
64.8 years
STANDARD_DEVIATION 5.91 • n=8 Participants
|
69.3 years
STANDARD_DEVIATION 4.84 • n=8 Participants
|
70.0 years
STANDARD_DEVIATION 5.90 • n=24 Participants
|
71.7 years
STANDARD_DEVIATION 6.62 • n=42 Participants
|
70.8 years
STANDARD_DEVIATION 6.62 • n=42 Participants
|
62.5 years
STANDARD_DEVIATION 6.16 • n=42 Participants
|
69.3 years
STANDARD_DEVIATION 8.71 • n=42 Participants
|
68.5 years
STANDARD_DEVIATION 6.55 • n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
44 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
33 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
52 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 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
|
7 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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
67 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
|
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
|
|
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
|
|
Mini Mental State Exam (MMSE)
|
21.8 MMSE score
STANDARD_DEVIATION 3.02 • n=5 Participants
|
22.0 MMSE score
STANDARD_DEVIATION 2.65 • n=7 Participants
|
22.3 MMSE score
STANDARD_DEVIATION 3.27 • n=5 Participants
|
22.5 MMSE score
STANDARD_DEVIATION 3.73 • n=4 Participants
|
22.2 MMSE score
STANDARD_DEVIATION 2.99 • n=21 Participants
|
21.0 MMSE score
STANDARD_DEVIATION 2.00 • n=8 Participants
|
23.2 MMSE score
STANDARD_DEVIATION 2.04 • n=8 Participants
|
22.1 MMSE score
STANDARD_DEVIATION 2.48 • n=24 Participants
|
19.8 MMSE score
STANDARD_DEVIATION 2.58 • n=42 Participants
|
20.2 MMSE score
STANDARD_DEVIATION 1.72 • n=42 Participants
|
20.0 MMSE score
STANDARD_DEVIATION 2.45 • n=42 Participants
|
22.5 MMSE score
STANDARD_DEVIATION 2.59 • n=42 Participants
|
21.6 MMSE score
STANDARD_DEVIATION 3.07 • n=36 Participants
|
PRIMARY outcome
Timeframe: 4 months SAD; 7 months MADPopulation: Safety Population
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
Outcome measures
| Measure |
Placebo: SAD
n=12 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=3 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=8 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
n=6 Participants
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
n=6 Participants
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tolerability as Measured by Participant Withdrawal for an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Pharmacokinetic Population (subjects treated with Medi1814)
Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
Outcome measures
| Measure |
Placebo: SAD
n=3 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=6 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=6 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)
Third dose (day 57-85)
|
NA ng x day/mL
Geometric Coefficient of Variation NA
single dose only
|
NA ng x day/mL
Geometric Coefficient of Variation NA
single dose only
|
NA ng x day/mL
Geometric Coefficient of Variation NA
single dose only
|
NA ng x day/mL
Geometric Coefficient of Variation NA
single dose only
|
NA ng x day/mL
Geometric Coefficient of Variation NA
single dose only
|
NA ng x day/mL
Geometric Coefficient of Variation NA
single dose only
|
1150 ng x day/mL
Geometric Coefficient of Variation 37.9
|
2680 ng x day/mL
Geometric Coefficient of Variation 74
|
7150 ng x day/mL
Geometric Coefficient of Variation 27.3
|
134 ng x day/mL
Geometric Coefficient of Variation 57.0
|
—
|
—
|
|
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)
First Dose (day 1-29)
|
80.5 ng x day/mL
Geometric Coefficient of Variation 61.1
|
455 ng x day/mL
Geometric Coefficient of Variation 19.7
|
1550 ng x day/mL
Geometric Coefficient of Variation 26.3
|
4040 ng x day/mL
Geometric Coefficient of Variation 28.0
|
4420 ng x day/mL
Geometric Coefficient of Variation 30.7
|
120 ng x day/mL
Geometric Coefficient of Variation 51.9
|
710 ng x day/mL
Geometric Coefficient of Variation 24.2
|
1690 ng x day/mL
Geometric Coefficient of Variation 75.3
|
4490 ng x day/mL
Geometric Coefficient of Variation 24.2
|
162 ng x day/mL
Geometric Coefficient of Variation 69.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Pharmacokinetic population (subjects dosed with Medi1814)
Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
Outcome measures
| Measure |
Placebo: SAD
n=3 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=6 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=6 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Medi1814
First dose (day 1-29)
|
10.2 ng/ml
Geometric Coefficient of Variation 42.7
|
38.7 ng/ml
Geometric Coefficient of Variation 30.9
|
102 ng/ml
Geometric Coefficient of Variation 14.7
|
341 ng/ml
Geometric Coefficient of Variation 19.3
|
424 ng/ml
Geometric Coefficient of Variation 36.1
|
3.59 ng/ml
Geometric Coefficient of Variation 51.4
|
83.9 ng/ml
Geometric Coefficient of Variation 22.3
|
172 ng/ml
Geometric Coefficient of Variation 77.2
|
496 ng/ml
Geometric Coefficient of Variation 24.4
|
10.1 ng/ml
Geometric Coefficient of Variation 81.4
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Medi1814
Third dose (day 57-85)
|
NA ng/ml
Geometric Coefficient of Variation NA
SAD - Day 1 dose only
|
NA ng/ml
Geometric Coefficient of Variation NA
SAD - Day 1 dose only
|
NA ng/ml
Geometric Coefficient of Variation NA
SAD - Day 1 dose only
|
NA ng/ml
Geometric Coefficient of Variation NA
SAD - Day 1 dose only
|
NA ng/ml
Geometric Coefficient of Variation NA
SAD - Day 1 dose only
|
NA ng/ml
Geometric Coefficient of Variation NA
SAD - Day 1 dose only
|
96.7 ng/ml
Geometric Coefficient of Variation 38.3
|
185 ng/ml
Geometric Coefficient of Variation 110
|
536 ng/ml
Geometric Coefficient of Variation 32.3
|
7.56 ng/ml
Geometric Coefficient of Variation 38.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Pharmacokinetic population (subjects dosed with Medi1814)
Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
Outcome measures
| Measure |
Placebo: SAD
n=3 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=6 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=6 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Termination Half Life (t 1/2) of Medi1814
First dose (day 1-29)
|
17.2 days
Standard Deviation 0.94
|
17.0 days
Standard Deviation 2.16
|
17.1 days
Standard Deviation 2.78
|
19.0 days
Standard Deviation 2.23
|
18.3 days
Standard Deviation 7.69
|
19.8 days
Standard Deviation 3.56
|
NA days
Standard Deviation NA
MAD not assessed after 1st dose
|
NA days
Standard Deviation NA
MAD not assessed after 1st dose
|
NA days
Standard Deviation NA
MAD not assessed after 1st dose
|
NA days
Standard Deviation NA
MAD not assessed after 1st dose
|
—
|
—
|
|
Mean Termination Half Life (t 1/2) of Medi1814
Third dose (day 57-85)
|
NA days
Standard Deviation NA
SAD had 1 dose only
|
NA days
Standard Deviation NA
SAD had 1 dose only
|
NA days
Standard Deviation NA
SAD had 1 dose only
|
NA days
Standard Deviation NA
SAD had 1 dose only
|
NA days
Standard Deviation NA
SAD had 1 dose only
|
NA days
Standard Deviation NA
SAD had 1 dose only
|
14.2 days
Standard Deviation 1.86
|
16.2 days
Standard Deviation 1.61
|
20.4 days
Standard Deviation 5.38
|
16.4 days
Standard Deviation 3.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 in SAD; Day 85 in MADPopulation: Pharmacodynamic population (with non zero baseline values)
Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Outcome measures
| Measure |
Placebo: SAD
n=12 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=3 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=8 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
n=6 Participants
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
n=6 Participants
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Free amyloid-beta 1-42
|
28.6 % change
Standard Deviation 113.70
|
-33.9 % change
Standard Deviation 13.98
|
-54.3 % change
Standard Deviation 39.96
|
-57.2 % change
Standard Deviation 55.80
|
-81.65 % change
Standard Deviation 21.67
|
-15.2 % change
Standard Deviation 189.05
|
-19.0 % change
Standard Deviation 17.69
|
-2.5 % change
Standard Deviation 62.66
|
11.6 % change
Standard Deviation 167.59
|
-96.3 % change
Standard Deviation 2.26
|
-95.0 % change
Standard Deviation 1.88
|
-57.7 % change
Standard Deviation 29.76
|
|
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Total amyloid-beta 1-40
|
122.9 % change
Standard Deviation 426.51
|
-15.9 % change
Standard Deviation 20.57
|
-21.0 % change
Standard Deviation 19.57
|
8.72 % change
Standard Deviation 31.69
|
2.0 % change
Standard Deviation 29.21
|
10.2 % change
Standard Deviation 98.14
|
-14.6 % change
Standard Deviation 23.69
|
4.96 % change
Standard Deviation 90.19
|
638.5 % change
Standard Deviation 1054.28
|
-17.9 % change
Standard Deviation 34.08
|
-36.96 % change
Standard Deviation 46.82
|
38.06 % change
Standard Deviation 47.51
|
|
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Total amyloid-beta 1-42
|
25.3 % change
Standard Deviation 100.71
|
52.0 % change
Standard Deviation 104.35
|
41.7 % change
Standard Deviation 38.68
|
192.8 % change
Standard Deviation 127.96
|
414.7 % change
Standard Deviation 292.18
|
376.1 % change
Standard Deviation 295.92
|
5.87 % change
Standard Deviation 24.52
|
-29.4 % change
Standard Deviation 55.90
|
633.6 % change
Standard Deviation 471.79
|
197.5 % change
Standard Deviation 115.25
|
915.5 % change
Standard Deviation 1361.86
|
87.8 % change
Standard Deviation 124.68
|
SECONDARY outcome
Timeframe: Day 29 in SAD; Day 85 in MADPopulation: Pharmacodynamic population (with non zero baseline values)
Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Outcome measures
| Measure |
Placebo: SAD
n=12 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=3 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=8 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
n=6 Participants
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
n=6 Participants
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Biomarker: Total Amyloid-beta 1-42 in Plasma
|
19.6 % change
Standard Deviation 34.51
|
40132.5 % change
Standard Deviation 4379.93
|
41107.0 % change
Standard Deviation 43509.89
|
46667.9 % change
Standard Deviation 29628.09
|
78534.5 % change
Standard Deviation 22773.96
|
44050.9 % change
Standard Deviation 15776.40
|
45404.0 % change
Standard Deviation 1808.13
|
-32.0 % change
Standard Deviation 45.65
|
30272.4 % change
Standard Deviation 14834.80
|
84652.8 % change
Standard Deviation 44649.16
|
43415.3 % change
Standard Deviation 13760.07
|
97140.1 % change
Standard Deviation 34151.47
|
SECONDARY outcome
Timeframe: SAD Day 29; MAD Day 85Population: Pharmacokinetic population (subjects dosed with Medi1814)
Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Outcome measures
| Measure |
Placebo: SAD
n=3 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=6 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=6 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Medi1814 Concentration in CSF Samples
First dose (day 1-29)
|
0 Participants
0.94
|
0 Participants
2.16
|
1 Participants
2.78
|
2 Participants
2.23
|
4 Participants
7.69
|
0 Participants
3.56
|
NA Participants
NA
MAD not assessed after first dose
|
NA Participants
NA
MAD not assessed after first dose
|
NA Participants
NA
MAD not assessed after first dose
|
NA Participants
NA
MAD not assessed after first dose
|
—
|
—
|
|
Medi1814 Concentration in CSF Samples
Third dose (day 57-85)
|
NA Participants
NA
SAD only 1 dose
|
NA Participants
NA
SAD only 1 dose
|
NA Participants
NA
SAD only 1 dose
|
NA Participants
NA
SAD only 1 dose
|
NA Participants
NA
SAD only 1 dose
|
NA Participants
NA
SAD only 1 dose
|
1 Participants
1.86
|
5 Participants
1.61
|
6 Participants
5.38
|
0 Participants
3.29
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)Population: Safety Population
Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all \<50
Outcome measures
| Measure |
Placebo: SAD
n=12 Participants
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=3 Participants
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 Participants
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 Participants
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 Participants
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 Participants
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC : SAD
n=6 Participants
Medi1814 100 mg SC: SAD cohort 6
|
Placebo: MAD
n=8 Participants
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 Participants
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 Participants
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
n=6 Participants
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
n=6 Participants
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity: Anti-drug Antibody Titer
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo: SAD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Medi1814 25 mg IV: SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Medi1814 100 mg IV: SAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medi1814 300 mg IV: SAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medi1814 900 mg IV: SAD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Medi1814 1800 mg IV: SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Medi1814 100 mg SC: SAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo: MAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medi1814 300 mg IV: MAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Medi1814 900 mg IV: MAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medi1814 1800 mg IV: MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Medi1814 200 mg SC: MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo: SAD
n=12 participants at risk
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV \& 6 SC (2 subjects each)
|
Medi1814 25 mg IV: SAD
n=3 participants at risk
Medi1814 25 mg IV: SAD cohort 1
|
Medi1814 100 mg IV: SAD
n=6 participants at risk
Medi1814 100 mg IV: SAD cohort 2
|
Medi1814 300 mg IV: SAD
n=6 participants at risk
Medi1814 300 mg IV: SAD cohort 3
|
Medi1814 900 mg IV: SAD
n=6 participants at risk
Medi1814 900 mg IV: SAD cohort 4
|
Medi1814 1800 mg IV: SAD
n=6 participants at risk
Medi1814 1800 mg IV: SAD cohort 5
|
Medi1814 100 mg SC: SAD
n=6 participants at risk
Medi1814 100 mg SC: CAD cohort 6
|
Placebo: MAD
n=8 participants at risk
Placebo: MAD pooled cohorts 7, 8, 9 IV \& 10 SC (2 subjects each)
|
Medi1814 300 mg IV: MAD
n=6 participants at risk
Medi1814 300 mg IV: MAD cohort 7
|
Medi1814 900 mg IV: MAD
n=6 participants at risk
Medi1814 900 mg IV: MAD cohort 8
|
Medi1814 1800 mg IV: MAD
n=6 participants at risk
Medi1814 1800 mg IV: MAD cohort 9
|
Medi1814 200 mg SC: MAD
n=6 participants at risk
Medi1814 200 mg SC: MAD cohort 10
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
General disorders
Fatigue
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Eye disorders
Macular degeneration
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
33.3%
2/6 • Number of events 2 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
General disorders
Injection site pain
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Paronychia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Infections and infestations
Viral infection
|
8.3%
1/12 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Investigations
C-reactive protein increased
|
8.3%
1/12 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
12.5%
1/8 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitis
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
33.3%
2/6 • Number of events 2 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
33.3%
1/3 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 4 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Psychiatric disorders
Nightmare
|
8.3%
1/12 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/3 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
16.7%
1/6 • Number of events 1 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/8 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
0.00%
0/6 • From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
|
Additional Information
Michael Pomfret, Project Director, IMED Neuroscience
AstraZeneca Pharmaceuticals
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place