Trial Outcomes & Findings for Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects (NCT NCT02573155)

Last Updated: 2018-11-08

Results Overview

An adverse event is the development of an undesirable medical condition, or the deterioration of a pre-existing medical condition, following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms, signs, or the abnormal results of laboratory parameters (haematology, blood chemistry, urinalysis, physical examination, 12-lead ECGs and telemetry, and vital signs). AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

134 participants

Primary outcome timeframe

From the time of informed consent up to 14 (±2) days after the last dose of investigational product. Unresolved AEs were followed up by the investigator for as long as medically indicated.

Results posted on

2018-11-08

Participant Flow

This study was conducted at 2 centres in the UK (one for each part). In part 1 of the study, the first patient was screened in October 2015 and the last patient visit was in March 2016. In part 2 of the study, the first patient was screened in April 2016 and the last patient visit was in August 2016.

2-part study: Part 1: single ascending doses of AZD8871 (planned 50, 100, 300, 600, 1200, 1800 μg; actual dose 50, 200, 400, 900, 1800, 2100 μg) or placebo over 3 treatment periods; 2 cohorts (male; mild persistent asthma). Part 2: 5-way complete cross-over, single-dose; M/F, moderate/severe COPD; 2 doses of AZD8871, placebo, or 2 active controls.

Participant milestones

Participant milestones
Measure	Overall Population - Part 1 All individuals in Part 1 (patients who received single doses of AZD8871 \[50, 400, 1800 μg for Cohort 1; 200, 900, 2100 μg for Cohort 2\], or placebo, in 3 treatment periods separated by washout periods of 14 days).	Overall Population - Part 2 All individuals involved in Part 2 (patients who received single doses of AZD8871 \[400 and 1800 μg\], placebo, indacaterol 150 μg, or tiotropium 18 μg, in 5 treatment periods separated by washout periods of 7-21 days.
Treatment Period 1 STARTED	16	38
Treatment Period 1 COMPLETED	16	38
Treatment Period 1 NOT COMPLETED	0	0
Washout Between Treatment Period 1 and 2 STARTED	16	38
Washout Between Treatment Period 1 and 2 COMPLETED	16	33
Washout Between Treatment Period 1 and 2 NOT COMPLETED	0	5
Period 2 STARTED	16	33
Period 2 COMPLETED	16	33
Period 2 NOT COMPLETED	0	0
Washout Between Treatment Period 2 and 3 STARTED	16	33
Washout Between Treatment Period 2 and 3 COMPLETED	15	31
Washout Between Treatment Period 2 and 3 NOT COMPLETED	1	2
Period 3 STARTED	15	31
Period 3 COMPLETED	15	31
Period 3 NOT COMPLETED	0	0
Washout Between Treatment Period 3 and 4 STARTED	0	31
Washout Between Treatment Period 3 and 4 COMPLETED	0	29
Washout Between Treatment Period 3 and 4 NOT COMPLETED	0	2
Period 4 STARTED	0	29
Period 4 COMPLETED	0	29
Period 4 NOT COMPLETED	0	0
Washout Between Treatment Period 4 and 5 STARTED	0	29
Washout Between Treatment Period 4 and 5 COMPLETED	0	28
Washout Between Treatment Period 4 and 5 NOT COMPLETED	0	1
Period 5 STARTED	0	28
Period 5 COMPLETED	0	28
Period 5 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Population - Part 1 All individuals in Part 1 (patients who received single doses of AZD8871 \[50, 400, 1800 μg for Cohort 1; 200, 900, 2100 μg for Cohort 2\], or placebo, in 3 treatment periods separated by washout periods of 14 days).	Overall Population - Part 2 All individuals involved in Part 2 (patients who received single doses of AZD8871 \[400 and 1800 μg\], placebo, indacaterol 150 μg, or tiotropium 18 μg, in 5 treatment periods separated by washout periods of 7-21 days.
Washout Between Treatment Period 1 and 2 Physician Decision	0	1
Washout Between Treatment Period 1 and 2 Withdrawal by Subject	0	1
Washout Between Treatment Period 1 and 2 Adverse Event	0	3
Washout Between Treatment Period 2 and 3 Sponsor's decision	1	0
Washout Between Treatment Period 2 and 3 Adverse Event	0	2
Washout Between Treatment Period 3 and 4 Stability/variability criteria not met	0	1
Washout Between Treatment Period 3 and 4 Adverse Event	0	1
Washout Between Treatment Period 4 and 5 Adverse Event	0	1

Baseline Characteristics

Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Population - Part 1 n=16 Participants All individuals in Part 1 (patients who received single doses of AZD8871 \[50, 400, 1800 μg for Cohort 1; 200, 900, 2100 μg for Cohort 2\], or placebo, in 3 treatment periods separated by washout periods of 14 days).	Overall Population - Part 2 n=38 Participants All individuals involved in Part 2 (patients who received single doses of AZD8871 \[400 and 1800 μg\], placebo, indacaterol 150 μg, or tiotropium 18 μg, in 5 treatment periods separated by washout periods of 7-21 days.	Total n=54 Participants Total of all reporting groups
Age, Continuous	39.0 Years STANDARD_DEVIATION 11.8 • n=93 Participants	65.6 Years STANDARD_DEVIATION 6.4 • n=4 Participants	NA Years STANDARD_DEVIATION NA • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	16 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	22 Participants n=4 Participants	38 Participants n=27 Participants

PRIMARY outcome

Timeframe: From the time of informed consent up to 14 (±2) days after the last dose of investigational product. Unresolved AEs were followed up by the investigator for as long as medically indicated.

Population: Safety population: all randomized subjects who received at least 1 dose of the investigational product.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 Participants Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 Participants Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
The Number of Participants With Mild Persistent Asthma (Part 1) and COPD (Part 2) With at Least 1 Treatment-emergent Adverse Event	5 Participants	5 Participants	3 Participants	3 Participants	3 Participants	2 Participants	7 Participants	18 Participants	7 Participants	12 Participants	11 Participants	11 Participants

PRIMARY outcome

Timeframe: From the time of informed consent up to 36 hours after last dose of IP.

Population: Safety population: all randomized subjects who received at least 1 dose of the investigational product

Blood pressure (BP) measurements (diastolic \[DBP\] and systolic BP \[SBP\]) taken after \~5 minutes rest in supine position, at screening, baseline (≤1 hour before IP administration), 10 and 30 minutes, 1, 2, 3, 4, 8, 12 hours (Day 1) and 24 and 36 hours (Day 2) after IP administration. Normal BP at screening: SBP 100-140 mmHg (subjects aged ≤59 years) and 100-150 mmHg (subjects aged ≥60 years), and DBP 40-90 mmHg. Criteria for notable changes in BP: High SBP: (≥180 and increase over baseline (predose) ≥20) or (≥200 and baseline \<200) Low SBP: (≤ 90 and decrease over baseline ≥20) or (≤75 and baseline \>75) High DBP: (≥105 and increase over baseline ≥15) or (≥115 and baseline \<115) Low DBP: (≤50 and decrease over baseline ≥15) or (≤40 and baseline \>40) All out of range values were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until considered non-clinically relevant.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 Participants Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 Participants Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Number of Participants With Clinically Relevant Abnormalities in Blood Pressure	0 Participants 8.7	0 Participants 2.1	0 Participants 4.3	0 Participants 7.2	0 Participants 3.4	0 Participants 11.7	0 Participants 5.7	0 Participants 8.3	0 Participants 4.5	0 Participants 6.3	0 Participants 6.8	0 Participants 9.6

PRIMARY outcome

Timeframe: From the time of informed consent up to 36 hours after last dose of IP.

Population: Safety population: all randomized subjects who received at least 1 dose of the investigational product

HR, QTcF and other ECG abnormalities were assessed by local digital 12-lead ECG performed in triplicate at the time points indicated: ECG (Parts 1 and 2) was assessed at Screening, Day 1 baseline, 10 min, 30 min, 1 hour (h), 2 h, 3 h, 4 h, 8 h, 12 h, 24 h, 36 h after dosing. Telemetry (Part 1), assessed with at least 2 lead real time display, was recorded at Day -1 (4-6 hours continuous recording, at the time this was more convenient for the logistics of the unit) and on Day 1 from the time of the IP administration up to at least 24 hours, but if advised by the Investigator or designee, then up to 36 hours after IP administration. Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 Participants Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 Participants Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Number of Participants With Clinically Relevant Abnormalities in Electrocardiograms (HR, QTcF and Other ECG Parameters).	0 Participants 4.5	0 Participants 3.9	0 Participants 3.7	0 Participants 3.2	0 Participants 5.2	0 Participants 4.8	0 Participants 6.2	0 Participants 6.2	0 Participants 7.7	0 Participants 5.5	0 Participants 4.7	0 Participants 6.1

PRIMARY outcome

Timeframe: From the time of informed consent up to 7 days after the last dose of IP.

Population: Safety population: all randomized subjects who received at least 1 dose of the investigational product

A composite of clinically relevant abnormalities in clinical biochemistry, hematology and urinalysis laboratory evaluations. Laboratory tests (haematology, blood chemistry, and urinalysis) were performed at screening, at Day -1 (Part 1 only), at 24 hours (Day 2) and at follow-up (7 \[±2\] days) after IP administration. Coagulation was only performed at screening; TSH, T4 only at screening, at Day-1 and at follow-up. Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 Participants Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 Participants Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Number of Participants With Clinically Relevant Abnormalities in Clinical Biochemistry, Hematology and Urinalysis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to 36 hours post-dose (Day 2)

Population: The PP population is defined as all randomised subjects who satisfied the main I/E criteria, received IP, completed at least 1 treatment period, and did not present major violations to the protocol

Pharmacodynamics of AZD8871 before (-45 min and -15 min pre-dose) and after single dosing of AZD8871 Forced expiratory volume in 1 second (FEV1) on Day 2 (defined as the average of the values 23:00 and 24:00 hours after the morning dose of investigational product)

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 Participants Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 Participants Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 2	-0.0375 Liters Standard Deviation 0.3449	0.2183 Liters Standard Deviation 0.1631	0.2883 Liters Standard Deviation 0.1418	0.1858 Liters Standard Deviation 0.3528	0.3275 Liters Standard Deviation 0.0708	0.4630 Liters Standard Deviation 0.2065	-0.0600 Liters Standard Deviation 0.3099	0.0738 Liters Standard Deviation 0.1212	0.1731 Liters Standard Deviation 0.1761	0.1036 Liters Standard Deviation 0.1286	0.1055 Liters Standard Deviation 0.1922	-0.0294 Liters Standard Deviation 0.0768

SECONDARY outcome

Timeframe: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose

Population: Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).

Cmax (maximum observed plasma drug concentrations) of AZD8871 on Day 1 of each treatment period.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Placebo (Part 1) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 2) n=18 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=15 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Cmax of AZD8871 in Parts 1 and 2	34.77 pg/mL Geometric Coefficient of Variation 60.77	174.1 pg/mL Geometric Coefficient of Variation 43.74	313.4 pg/mL Geometric Coefficient of Variation 46.56	797.3 pg/mL Geometric Coefficient of Variation 20.99	1351 pg/mL Geometric Coefficient of Variation 20.32	1243 pg/mL Geometric Coefficient of Variation 24.33	—	199.3 pg/mL Geometric Coefficient of Variation 37.40	810.8 pg/mL Geometric Coefficient of Variation 36.59	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose

tmax (time to reach maximum concentration) of AZD8871 on Day 1 of each treatment period.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Placebo (Part 1) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 2) n=18 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=15 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Tmax of AZD8871 in Parts 1 and 2	0.88 Hours Interval 0.52 to 1.03	0.86 Hours Interval 0.48 to 1.0	1.00 Hours Interval 0.75 to 1.05	1.00 Hours Interval 0.98 to 1.02	1.49 Hours Interval 0.73 to 2.03	1.02 Hours Interval 1.0 to 2.0	—	1.00 Hours Interval 0.75 to 3.0	2.00 Hours Interval 0.75 to 3.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose

AUC(0-t) (area under the concentration-time curve from time zero to time of the last quantifiable measurable concentration) of AZD8871 on Day 1 of each treatment period.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Placebo (Part 1) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 2) n=16 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=15 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
AUC(0-t) of AZD8871 in Parts 1 and 2	110 pg*h/mL Geometric Coefficient of Variation 69.17	631.3 pg*h/mL Geometric Coefficient of Variation 30.40	1397 pg*h/mL Geometric Coefficient of Variation 31.41	3299 pg*h/mL Geometric Coefficient of Variation 27.00	6055 pg*h/mL Geometric Coefficient of Variation 24.98	6418 pg*h/mL Geometric Coefficient of Variation 35.13	—	1239 pg*h/mL Geometric Coefficient of Variation 37.70	6159 pg*h/mL Geometric Coefficient of Variation 44.30	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose

AUC(0-24) (area under the concentration-time curve from zero to 24h) of AZD8871 on Day 1 of each treatment period.

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Placebo (Part 1) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 2) n=18 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=15 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
AUC(0-24) of AZD8871 in Parts 1 and 2	118.9 pg*h/mL Geometric Coefficient of Variation 60.19	567.9 pg*h/mL Geometric Coefficient of Variation 29.74	1265 pg*h/mL Geometric Coefficient of Variation 32.44	3020 pg*h/mL Geometric Coefficient of Variation 25.71	5587 pg*h/mL Geometric Coefficient of Variation 25.40	5922 pg*h/mL Geometric Coefficient of Variation 34.32	—	1195 pg*h/mL Geometric Coefficient of Variation 38.91	5659 pg*h/mL Geometric Coefficient of Variation 43.68	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose, and 5 min, 15 min, 30 min, and 45 min, at 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h and 36 h (Day 2) post-dose

AUC (area under the concentration-time curve from time 0 to infinity) of AZD8871 on Day 1 of each treatment period

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Placebo (Part 1) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 2) n=18 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=15 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
AUC of AZD8871 in Parts 1 and 2	123.1 pg*h/mL Geometric Coefficient of Variation 75.48	774.5 pg*h/mL Geometric Coefficient of Variation 32.64	1671 pg*h/mL Geometric Coefficient of Variation 28.54	3831 pg*h/mL Geometric Coefficient of Variation 28.72	6941 pg*h/mL Geometric Coefficient of Variation 22.23	7164 pg*h/mL Geometric Coefficient of Variation 34.10	—	1459 pg*h/mL Geometric Coefficient of Variation 39.19	6769 pg*h/mL Geometric Coefficient of Variation 44.65	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose, and 5 min, 15 min, 30 min, and 45 min, at 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h and 36 h (Day 2) post-dose

Elimination half-life (t½λz) for AZD8871 on Day 1 of each treatment period. t½λz was generally calculated over a period of less than 3 times the resultant half-life

Outcome measures

Outcome measures
Measure	AZD8871 50 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Placebo (Part 1) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 2) n=18 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=15 Participants Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Elimination Half-life of AZD8871 in Parts 1 and 2	9.439 Hours Standard Deviation 7.350	23.10 Hours Standard Deviation 2.809	20.81 Hours Standard Deviation 5.384	18.86 Hours Standard Deviation 3.959	19.29 Hours Standard Deviation 5.468	15.96 Hours Standard Deviation 2.789	—	14.20 Hours Standard Deviation 5.521	12.89 Hours Standard Deviation 2.268	—	—	—

Adverse Events

AZD8871 50 μg (Part 1)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

AZD8871 200 μg (Part 1)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

AZD8871 400 μg (Part 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AZD8871 900 μg (Part 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AZD8871 1800 μg (Part 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AZD8871 2100 μg (Part 1)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (Part 1)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

AZD8871 400 μg (Part 2)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

AZD8871 1800 μg (Part 2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Indacaterol 150 μg (Part 2)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Tiotropium 18 μg (Part 2)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo (Part 2)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AZD8871 50 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 participants at risk Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 participants at risk Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	3.3% 1/30 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Social circumstances Physical assault	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	2.9% 1/34 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.

Other adverse events

Other adverse events
Measure	AZD8871 50 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 200 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 400 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 900 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 1) n=6 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 2100 μg (Part 1) n=5 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)	AZD8871 400 μg (Part 2) n=34 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	AZD8871 1800 μg (Part 2) n=31 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)	Indacaterol 150 μg (Part 2) n=32 participants at risk Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)	Tiotropium 18 μg (Part 2) n=30 participants at risk Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)	Placebo (Part 2) n=32 participants at risk Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Infections and infestations Nasopharyngitis	50.0% 3/6 • Number of events 3 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	40.0% 2/5 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	2.9% 1/34 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	3.2% 1/31 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	6.2% 2/32 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	3.3% 1/30 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	3.1% 1/32 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Nervous system disorders Headache	50.0% 3/6 • Number of events 6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	33.3% 2/6 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	33.3% 2/6 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	25.0% 3/12 • Number of events 3 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	14.7% 5/34 • Number of events 5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	9.7% 3/31 • Number of events 4 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	12.5% 4/32 • Number of events 4 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	23.3% 7/30 • Number of events 7 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	21.9% 7/32 • Number of events 7 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disorder	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	5.9% 2/34 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	3.2% 1/31 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	3.1% 1/32 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
General disorders Feeling hot	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	20.0% 1/5 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
General disorders Catheter site pain	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
General disorders Chest discomfort	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 4 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
General disorders Chest pain	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
General disorders Fatigue	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Immune system disorders Seasonal allergy	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Infections and infestations Abscess oral	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Infections and infestations Oral herpes	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Infections and infestations Bronchitis	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Infections and infestations Pharyngitis	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Infections and infestations Bronchitis viral	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	20.0% 1/5 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Nervous system disorders Dizziness	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Nervous system disorders Dizziness postural	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Nervous system disorders Presyncope	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Respiratory, thoracic and mediastinal disorders Wheezing	16.7% 1/6 • Number of events 4 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	8.3% 1/12 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Skin and subcutaneous tissue disorders Skin irritation	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 2 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	16.7% 1/6 • Number of events 1 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/6 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/5 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/12 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/34 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/31 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/30 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.	0.00% 0/32 • From the time of informed consent up to 14 (±2) days after the last dose of investigational product (IP). Treatment-emergent adverse events were those reported after the first dose of IP up to 14 (±2) days after the last dose of IP. Unresolved AEs were followed up by the investigator for as long as medically indicated. The Safety population comprised all randomised subjects who received at least 1 dose of the IP.

Additional Information

Study Director

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of the results by the Principal Investigator (PI) will be subject to mutual agreement between the PI and the sponsor.
Publication restrictions are in place

Restriction type: OTHER