Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants (NCT NCT04828343)
NCT ID: NCT04828343
Last Updated: 2024-03-07
Results Overview
A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
Results posted on
2024-03-07
Participant Flow
The study started to enroll participants in April 2021 and concluded in April 2022.
The Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
33.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
39.3 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=8 Participants
|
45.5 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
NA years
STANDARD_DEVIATION NA • n=24 Participants
|
37.4 years
STANDARD_DEVIATION 12.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other or Mixed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)Population: The Safety Analysis Set (SS) included all randomized study participants who received IMP.
A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
83.3 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
83.3 percentage of participants
|
0 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16Population: The Pharmacokinetic Per Protocol Set (PK-PPS) included all study participants who received active study medication and had at least 1 observable PK measurement and had no important protocol deviation (IPDs) affecting the PK parameters. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
Cmax was the maximum plasma concentration of a single dose rozanolixizumab. Cmax was measured in micrograms per millilitre per milligram (ug/mL/mg).
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=4 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=5 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab
|
0.03352 ug/mL/mg
Geometric Coefficient of Variation 52.8
|
0.004066 ug/mL/mg
Geometric Coefficient of Variation 127.0
|
0.007293 ug/mL/mg
Geometric Coefficient of Variation 644.1
|
0.02752 ug/mL/mg
Geometric Coefficient of Variation 82.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16Population: The Pharmacokinetic Per Protocol Set (PK-PPS) included all study participants who received active study medication and had at least 1 observable PK measurement and had no IPDs affecting the PK parameters. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
tmax was the time to maximum plasma concentration of a single dose rozanolixizumab.
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=4 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=5 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab
|
60.10 hours
Interval 36.0 to 72.4
|
48.03 hours
Interval 36.0 to 72.1
|
72.00 hours
Interval 36.0 to 96.3
|
72.00 hours
Interval 36.0 to 96.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16Population: The Pharmacokinetic Per Protocol Set (PK-PPS) included all study participants who received active study medication and had at least 1 observable PK measurement and had no IPDs affecting the PK parameters. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
AUC0-t was the area under the plasma concentration-time curve from time zero to time t of a single dose rozanolixizumab.
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=4 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=5 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab
|
2.408 hours*ug/mL/mg
Geometric Coefficient of Variation 55.4
|
0.1436 hours*ug/mL/mg
Geometric Coefficient of Variation 266.7
|
0.4223 hours*ug/mL/mg
Geometric Coefficient of Variation 687.0
|
2.111 hours*ug/mL/mg
Geometric Coefficient of Variation 80.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57Population: Pharmacodynamic Per Protocol Set (PD-PPS) was a subset of the Safety Set (SS) which included study participants who had no IPDs affecting the PD variables, as confirmed during a pre-analysis review of the data prior to database lock. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
Area under the baseline-corrected total IgG response curve from time 0 to time t.
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=5 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
n=5 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve
|
-190.6 grams*day/Litre (g*day/L)
Standard Deviation 66.10
|
NA grams*day/Litre (g*day/L)
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and standard deviation (SD) were not calculated.
|
-101.0 grams*day/Litre (g*day/L)
Standard Deviation 118.4
|
NA grams*day/Litre (g*day/L)
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
-141.8 grams*day/Litre (g*day/L)
Standard Deviation 52.99
|
NA grams*day/Litre (g*day/L)
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
-168.8 grams*day/Litre (g*day/L)
Standard Deviation 49.70
|
NA grams*day/Litre (g*day/L)
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
SECONDARY outcome
Timeframe: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57Population: Pharmacodynamic Per Protocol Set (PD-PPS) was a subset of the Safety Set (SS) which included study participants who had no IPDs affecting the PD variables, as confirmed during a pre-analysis review of the data prior to database lock.
Rmin was the maximum (max) decrease in total plasma IgG of a single dose rozanolixizumab or placebo.
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo
|
-46.73 percent max decrease in total plasma IgG
Standard Deviation 14.76
|
NA percent max decrease in total plasma IgG
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
-42.14 percent max decrease in total plasma IgG
Standard Deviation 13.31
|
NA percent max decrease in total plasma IgG
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
-44.03 percent max decrease in total plasma IgG
Standard Deviation 8.711
|
NA percent max decrease in total plasma IgG
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
-42.90 percent max decrease in total plasma IgG
Standard Deviation 10.67
|
NA percent max decrease in total plasma IgG
Standard Deviation NA
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, mean and SD were not calculated.
|
SECONDARY outcome
Timeframe: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57Population: Pharmacodynamic Per Protocol Set (PD-PPS) was a subset of the Safety Set (SS) which included study participants who had no IPDs affecting the PD variables, as confirmed during a pre-analysis review of the data prior to database lock.
tmin was the time to minimum IgG level of a single dose rozanolixizumab or placebo.
Outcome measures
| Measure |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=2 Participants
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
n=6 Participants
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
n=2 Participants
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo
|
12.08 days
Interval 8.98 to 42.0
|
NA days
Interval 6.08 to 9.16
As pre-specified in the SAP, if n was less than (\<) 3, only the minimum and maximum were reported, median could not be calculated.
|
11.07 days
Interval 6.11 to 15.1
|
NA days
Interval 4.0 to 42.1
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, median could not be calculated.
|
9.012 days
Interval 5.97 to 12.1
|
NA days
Interval 5.96 to 15.1
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, median could not be calculated.
|
10.55 days
Interval 4.0 to 15.0
|
NA days
Interval 2.0 to 8.95
As pre-specified in the SAP, if n\<3, only the minimum and maximum were reported, median could not be calculated.
|
Adverse Events
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3: Syringe Driver- PBO (>=50 kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: Manual Push- PBO (>=50 kg)
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 |
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)
n=6 participants at risk
Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)
n=2 participants at risk
Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)
n=6 participants at risk
Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study.
|
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)
n=2 participants at risk
Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)
n=6 participants at risk
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 3: Syringe Driver- PBO (>=50 kg)
n=2 participants at risk
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study.
|
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)
n=6 participants at risk
Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study.
|
Cohort 4: Manual Push- PBO (>=50 kg)
n=2 participants at risk
Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Infusion site erythema
|
50.0%
3/6 • Number of events 3 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
General disorders
Infusion site pain
|
33.3%
2/6 • Number of events 3 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
1/2 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
1/2 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
1/2 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
1/2 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
3/6 • Number of events 3 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
General disorders
Infusion site bruising
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
General disorders
Infusion site swelling
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
General disorders
Infusion site pruritus
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
1/2 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Investigations
Occult blood positive
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Number of events 4 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
3/6 • Number of events 3 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
33.3%
2/6 • Number of events 2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
50.0%
1/2 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/6 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
0.00%
0/2 • From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60