Trial Outcomes & Findings for Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD (NCT NCT02059434)
NCT ID: NCT02059434
Last Updated: 2019-06-21
Results Overview
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
55 participants
Primary outcome timeframe
30 Days
Results posted on
2019-06-21
Participant Flow
This study was conducted at 2 centres in the UK. In part 1 of the study, the first patient was screened in September 2013 and the last patient visit was in February 2014. In part 2 of the study, the first patient was screened in March 2014 and the last patient visit was in October 2014.
This was a 2-part study. Part 1: incomplete crossover, single ascending dose study of 2 cohorts randomised to fixed sequences of LAS190792 or placebo in 3 treatment periods. Part 2: 5-way complete crossover, single dose study of LAS190792 (100/400 μg), placebo, or active controls (indacaterol 150 μg, tiotropium 18 μg) in 5 treatment periods.
Participant milestones
| Measure |
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, 200 μg
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 Placebo, Then LAS190792 50 μg, 200 μg
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence Placebo, then LAS190792 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 LAS190792 5 μg, Placebo, LAS190792 200 μg
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, Placebo, LAS190792 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, Then Placebo
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, 400 μg
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 Placebo, Then LAS190792 100 μg, 400 μg
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence Placebo, then LAS190792 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, Placebo, LAS190792 400 μg
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, Placebo, LAS190792 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, Then Placebo
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
|
Overall Population - Part 2
All individuals involved in Part 2 (single-dose study of two doses of LAS190792 \[100 and 400 μg\], indacaterol, tiotropium or placebo, in 5 treatment periods separated by washout periods of 7-14 days).
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Reasons for withdrawal
| Measure |
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, 200 μg
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 Placebo, Then LAS190792 50 μg, 200 μg
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence Placebo, then LAS190792 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 LAS190792 5 μg, Placebo, LAS190792 200 μg
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, Placebo, LAS190792 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, Then Placebo
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, 400 μg
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 Placebo, Then LAS190792 100 μg, 400 μg
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence Placebo, then LAS190792 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, Placebo, LAS190792 400 μg
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, Placebo, LAS190792 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, Then Placebo
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
|
Overall Population - Part 2
All individuals involved in Part 2 (single-dose study of two doses of LAS190792 \[100 and 400 μg\], indacaterol, tiotropium or placebo, in 5 treatment periods separated by washout periods of 7-14 days).
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Washout Between Periods 1 and 2
Physician Decision
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Washout Between Periods 4 and 5
Adverse Event
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Washout Between Periods 6 and 7
Physician Decision
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Washout Between Periods 7 and 8
Adverse Event
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Washout Between Periods 7 and 8
Withdrawal by Subject
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1
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Baseline Characteristics
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
Baseline characteristics by cohort
| Measure |
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, 200 μg
n=2 Participants
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 Placebo, Then LAS190792 50 μg, 200 μg
n=2 Participants
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence Placebo, then LAS190792 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 LAS190792 5 μg, Placebo, LAS190792 200 μg
n=2 Participants
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, Placebo, LAS190792 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, Then Placebo
n=2 Participants
All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, 400 μg
n=2 Participants
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 Placebo, Then LAS190792 100 μg, 400 μg
n=2 Participants
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence Placebo, then LAS190792 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, Placebo, LAS190792 400 μg
n=2 Participants
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, Placebo, LAS190792 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
|
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, Then Placebo
n=3 Participants
All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
|
Overall Population - Part 2
n=38 Participants
All individuals involved in Part 2 (single-dose study of two doses of LAS190792 \[100 and 400 μg\], indacaterol, tiotropium or placebo, in 5 treatment periods separated by washout periods of 7-14 days).
|
Total
n=55 Participants
Total of all reporting groups
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|---|---|---|---|---|---|---|---|---|---|---|
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Age, Continuous
Part 1
|
35 Years
STANDARD_DEVIATION 8.5 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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34.5 Years
STANDARD_DEVIATION 20.5 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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35 Years
STANDARD_DEVIATION 4.2 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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37 Years
STANDARD_DEVIATION 19.8 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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32.5 Years
STANDARD_DEVIATION 6.4 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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41.5 Years
STANDARD_DEVIATION 29.0 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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28 Years
STANDARD_DEVIATION 1.4 • n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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34.3 Years
STANDARD_DEVIATION 12.7 • n=3 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
—
|
34.7 Years
STANDARD_DEVIATION 12.0 • n=17 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
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Age, Continuous
Part 2
|
—
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—
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—
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—
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—
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—
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—
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—
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60.4 Years
STANDARD_DEVIATION 5.9 • n=38 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
60.4 Years
STANDARD_DEVIATION 5.9 • n=38 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
|
Sex: Female, Male
Part 1 · Female
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=3 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
n=17 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
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Sex: Female, Male
Part 1 · Male
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
2 Participants
n=2 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
3 Participants
n=3 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
17 Participants
n=17 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
|
Sex: Female, Male
Part 2 · Female
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
18 Participants
n=38 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
18 Participants
n=38 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
|
Sex: Female, Male
Part 2 · Male
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
0 Participants
Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
20 Participants
n=38 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
20 Participants
n=38 Participants • Baseline characteristics for participants randomised in Part 1 - Cohorts 1 and 2 treatment sequences (incomplete crossover design) and overall in Part 2 (due to 5-way crossover design), respectively.
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Safety Population: defined as all randomized subjects who received at least one dose of the investigational product
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
LAS190792 5 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=36 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
n=35 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
n=37 Participants
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
n=37 Participants
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
n=37 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subjects With ≥1 Treatment-emergent Adverse Event
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
12 Participants
|
12 Participants
|
14 Participants
|
21 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: Per Protocol Population: defined as all randomized subjects who satisfied the main inclusion / exclusion criteria, received investigational product, completed at least one treatment period, and did not present major violations to the protocol.
Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.
Outcome measures
| Measure |
LAS190792 5 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=36 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
n=35 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
n=37 Participants
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
n=37 Participants
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
n=37 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)
|
-0.013 Liters
Standard Deviation 0.333
|
0.161 Liters
Standard Deviation 0.131
|
0.523 Liters
Standard Deviation 0.448
|
0.536 Liters
Standard Deviation 0.170
|
0.371 Liters
Standard Deviation 0.333
|
0.599 Liters
Standard Deviation 0.316
|
0.029 Liters
Standard Deviation 0.144
|
1.369 Liters
Standard Deviation 0.505
|
1.360 Liters
Standard Deviation 0.472
|
1.379 Liters
Standard Deviation 0.502
|
1.361 Liters
Standard Deviation 0.481
|
1.338 Liters
Standard Deviation 0.506
|
SECONDARY outcome
Timeframe: Up to 36 hours after investigational product administrationPopulation: Pharmacokinetic population: defined as all randomized subjects who received at least one dose of investigational product in at least one treatment period and have evaluable PK parameters
Outcome measures
| Measure |
LAS190792 5 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=10 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
NA pg/mL
Standard Deviation NA
With a lower limit of quantification (LLOQ) of 5 pg/mL, LAS190792 was not measurable in plasma following single doses of 5 µg
|
NA pg/mL
Standard Deviation NA
With a LLOQ of 5 pg/mL, LAS190792 was not measurable in plasma following single doses of 20 μg, with the exception of one single sample (5.07 pg/mL) corresponding to a kinetic time-point of 0.5 h
|
8.79 pg/mL
Standard Deviation 4.86
|
19.5 pg/mL
Standard Deviation 8.45
|
43.9 pg/mL
Standard Deviation 16.8
|
59.7 pg/mL
Standard Deviation 19.2
|
15.4 pg/mL
Standard Deviation 6.39
|
56.2 pg/mL
Standard Deviation 10.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36 hours after investigational product administrationPopulation: Pharmacokinetic population: defined as all randomized subjects who received at least one dose of investigational product in at least one treatment period and have evaluable PK parameters
Outcome measures
| Measure |
LAS190792 5 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=10 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax)
|
NA Hours
With a lower limit of quantification (LLOQ) of 5 pg/mL, LAS190792 was not measurable in plasma following single doses of 5 µg
|
NA Hours
With a LLOQ of 5 pg/mL, LAS190792 was not measurable in plasma following single doses of 20 μg, with the exception of one single sample (5.07 pg/mL) corresponding to a kinetic time-point of 0.5 h.
|
0.25 Hours
Interval 0.25 to 0.5
|
0.5 Hours
Interval 0.28 to 0.75
|
0.375 Hours
Interval 0.25 to 0.5
|
0.517 Hours
Interval 0.25 to 0.75
|
0.5 Hours
Interval 0.25 to 0.75
|
0.517 Hours
Interval 0.317 to 1.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36 hours after investigational product administrationPopulation: Pharmacokinetic population: defined as all randomized subjects who received at least one dose of investigational product in at least one treatment period and have evaluable PK parameters
Outcome measures
| Measure |
LAS190792 5 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=10 Participants
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Zero to the Time of the Last Measurable Concentration
|
NA pg.h/mL
Standard Deviation NA
With a lower limit of quantification (LLOQ) of 5 pg/mL, LAS190792 was not measurable in plasma following single doses of 5 µg
|
0.106 pg.h/mL
Standard Deviation 0.259
|
5.50 pg.h/mL
Standard Deviation 3.53
|
20.1 pg.h/mL
Standard Deviation 17.3
|
82.7 pg.h/mL
Standard Deviation 43.3
|
122 pg.h/mL
Standard Deviation 57.1
|
20.5 pg.h/mL
Standard Deviation 15.4
|
127 pg.h/mL
Standard Deviation 67.2
|
—
|
—
|
—
|
—
|
Adverse Events
LAS190792 5 µg (Part 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LAS190792 20 µg (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LAS190792 50 µg (Part 1)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
LAS190792 100 µg (Part 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LAS190792 200 µg (Part 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LAS190792 400 µg (Part 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LAS190792 100 µg (Part 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LAS190792 400 µg (Part 2)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Tiotropium 18 μg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Indacaterol 150 μg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo (Part 2)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LAS190792 5 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=36 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
n=35 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
n=37 participants at risk
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
n=37 participants at risk
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
n=37 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
Other adverse events
| Measure |
LAS190792 5 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 20 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 50 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 200 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 1)
n=6 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Placebo (Part 1)
n=12 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 100 µg (Part 2)
n=36 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
LAS190792 400 µg (Part 2)
n=35 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
Tiotropium 18 μg
n=37 participants at risk
Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
|
Indacaterol 150 μg
n=37 participants at risk
Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
|
Placebo (Part 2)
n=37 participants at risk
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.9%
1/35 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
8.3%
1/12 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
33.3%
2/6 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
33.3%
2/6 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
2/12 • Number of events 3 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
8.3%
3/36 • Number of events 4 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
14.3%
5/35 • Number of events 7 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.2%
6/37 • Number of events 7 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
21.6%
8/37 • Number of events 8 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
10.8%
4/37 • Number of events 6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
33.3%
2/6 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.8%
1/36 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
8.3%
1/12 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.8%
1/36 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
5.4%
2/37 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
8.6%
3/35 • Number of events 3 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
5.7%
2/35 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/36 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
5.7%
2/35 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
5.6%
2/36 • Number of events 3 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.7%
1/37 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
16.2%
6/37 • Number of events 6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
5.4%
2/37 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/6 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/12 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
2.8%
1/36 • Number of events 1 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/35 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
0.00%
0/37 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
5.4%
2/37 • Number of events 2 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
8.1%
3/37 • Number of events 3 • Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
The Safety population comprised all randomised participants who received at least one dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication and / or presentation whether complete or partial, of any part of the data or results of this study will not be allowed until global publication and study results disclosure by the sponsor as per EMA / FDA regulatory compliance obligations, and only after mutual agreement between the Investigator and AstraZemeca
- Publication restrictions are in place
Restriction type: OTHER