Trial Outcomes & Findings for Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids (NCT NCT04643158)

NCT ID: NCT04643158

Last Updated: 2025-08-28

Results Overview

The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: From Screening (Week -6) until Follow-up (Day 56)
• Results posted on: 2025-08-28

Participant Flow

This study was conducted from 21 April 2021 to 20 July 2023 at 63 study centers in 10 countries.

The screening period was of 2 weeks (Week -6 to Week -4) for both parts of the study. Informed Consent Form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment. Participants who met the eligibility criteria were randomized to study intervention in addition to receiving background local standard of care therapy.

Participant milestones

Measure	Part 1: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via dry powder inhaler (DPI).	Part 1: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Overall Study STARTED	11	10	13	16	4	9	9
Overall Study COMPLETED	11	10	11	16	4	7	9
Overall Study NOT COMPLETED	0	0	2	0	0	2	0

Reasons for withdrawal

Measure	Part 1: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via dry powder inhaler (DPI).	Part 1: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Overall Study Study terminated by sponsor	0	0	1	0	0	1	0
Overall Study Global/country situation	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	1	0

Baseline Characteristics

Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids

Baseline characteristics by cohort

Measure	Part 1: AZD1402 Dose 1 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo n=9 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Total n=72 Participants Total of all reporting groups
Age, Continuous	46.3 Years STANDARD_DEVIATION 11.5 • n=5 Participants	43.6 Years STANDARD_DEVIATION 15.2 • n=7 Participants	47.0 Years STANDARD_DEVIATION 17.6 • n=5 Participants	50.0 Years STANDARD_DEVIATION 10.8 • n=4 Participants	60.3 Years STANDARD_DEVIATION 10.2 • n=21 Participants	61.3 Years STANDARD_DEVIATION 6.5 • n=8 Participants	61.7 Years STANDARD_DEVIATION 6.6 • n=8 Participants	52.9 Years STANDARD_DEVIATION 7.3 • n=24 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	40 Participants n=24 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	32 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=8 Participants	9 Participants n=8 Participants	71 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: From Screening (Week -6) until Follow-up (Day 56)

Population: The safety set included all patients who were randomised and received any investigational product (IP).

The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1: Number of Participants With Adverse Events (AEs) Any AE	4 Participants	6 Participants	10 Participants	8 Participants	—	—	—
Part 1: Number of Participants With Adverse Events (AEs) Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 1: Number of Participants With Adverse Events (AEs) Any SAE with outcome death	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 1: Number of Participants With Adverse Events (AEs) Any AE leading to discontinuation of IP	0 Participants	1 Participants	1 Participants	1 Participants	—	—	—
Part 1: Number of Participants With Adverse Events (AEs) Any AE leading to withdrawal from study	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: The full analysis set included all patients who were randomised and received any IP.

The efficacy of inhaled AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in Pre-bronchodilator FEV1	-0.0195 Liters (L) Standard Error 0.1023	0.1529 Liters (L) Standard Error 0.0804	-0.0431 Liters (L) Standard Error 0.0777	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 12, Day 16, and Day 56

Population: The safety set included all patients who were randomised and received any IP.

The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Baseline	0.225 milligrams per deciliter (mg/dL) Standard Deviation 0.369	0.109 milligrams per deciliter (mg/dL) Standard Deviation 0.080	0.102 milligrams per deciliter (mg/dL) Standard Deviation 0.070	0.094 milligrams per deciliter (mg/dL) Standard Deviation 0.090	—	—	—
Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Day 12	0.167 milligrams per deciliter (mg/dL) Standard Deviation 0.247	0.650 milligrams per deciliter (mg/dL) Standard Deviation 1.898	0.485 milligrams per deciliter (mg/dL) Standard Deviation 0.542	0.103 milligrams per deciliter (mg/dL) Standard Deviation 0.173	—	—	—
Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Day 16	0.727 milligrams per deciliter (mg/dL) Standard Deviation 1.906	0.166 milligrams per deciliter (mg/dL) Standard Deviation 0.171	1.093 milligrams per deciliter (mg/dL) Standard Deviation 1.761	0.088 milligrams per deciliter (mg/dL) Standard Deviation 0.091	—	—	—
Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Day 56	0.172 milligrams per deciliter (mg/dL) Standard Deviation 0.243	0.094 milligrams per deciliter (mg/dL) Standard Deviation 0.095	0.119 milligrams per deciliter (mg/dL) Standard Deviation 0.081	0.112 milligrams per deciliter (mg/dL) Standard Deviation 0.151	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56

Population: The safety set included all patients who were randomised and received any IP.

The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1: Change From Baseline in FEV1 In-clinic Spirometry Day 56	-0.2239 Liters (L) Standard Deviation 0.2096	-0.1232 Liters (L) Standard Deviation 0.1455	-0.0830 Liters (L) Standard Deviation 0.1802	-0.1707 Liters (L) Standard Deviation 0.2345	—	—	—
Part 1: Change From Baseline in FEV1 In-clinic Spirometry Day 1 evening	-0.0338 Liters (L) Standard Deviation 0.1794	-0.2416 Liters (L) Standard Deviation 0.4113	0.0031 Liters (L) Standard Deviation 0.1841	0.0318 Liters (L) Standard Deviation 0.1362	—	—	—
Part 1: Change From Baseline in FEV1 In-clinic Spirometry Day 7 morning	-0.1225 Liters (L) Standard Deviation 0.1290	-0.2134 Liters (L) Standard Deviation 0.1975	0.0187 Liters (L) Standard Deviation 0.1338	-0.0913 Liters (L) Standard Deviation 0.2121	—	—	—
Part 1: Change From Baseline in FEV1 In-clinic Spirometry Day 7 evening	-0.0648 Liters (L) Standard Deviation 0.1579	-0.0884 Liters (L) Standard Deviation 0.1082	0.0430 Liters (L) Standard Deviation 0.1613	0.0486 Liters (L) Standard Deviation 0.1474	—	—	—
Part 1: Change From Baseline in FEV1 In-clinic Spirometry Day 14 morning	-0.1157 Liters (L) Standard Deviation 0.1231	-0.1776 Liters (L) Standard Deviation 0.1533	-0.0388 Liters (L) Standard Deviation 0.2225	-0.0773 Liters (L) Standard Deviation 0.1584	—	—	—
Part 1: Change From Baseline in FEV1 In-clinic Spirometry Day 28 morning	-0.2199 Liters (L) Standard Deviation 0.1933	-0.1673 Liters (L) Standard Deviation 0.2192	-0.0583 Liters (L) Standard Deviation 0.1515	-0.2050 Liters (L) Standard Deviation 0.2290	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Day 56 morning	14.17 Part per billion (ppb) Geometric Coefficient of Variation 174.36	19.31 Part per billion (ppb) Geometric Coefficient of Variation 62.10	21.44 Part per billion (ppb) Geometric Coefficient of Variation 212.81	15.51 Part per billion (ppb) Geometric Coefficient of Variation 106.64	—	—	—
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Day 1 evening	12.14 Part per billion (ppb) Geometric Coefficient of Variation 123.28	17.14 Part per billion (ppb) Geometric Coefficient of Variation 356.42	13.52 Part per billion (ppb) Geometric Coefficient of Variation 162.23	13.30 Part per billion (ppb) Geometric Coefficient of Variation 150.60	—	—	—
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Day 7 morning	11.60 Part per billion (ppb) Geometric Coefficient of Variation 243.83	23.71 Part per billion (ppb) Geometric Coefficient of Variation 132.90	21.55 Part per billion (ppb) Geometric Coefficient of Variation 95.95	17.61 Part per billion (ppb) Geometric Coefficient of Variation 93.96	—	—	—
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Day 7 evening	16.81 Part per billion (ppb) Geometric Coefficient of Variation 102.28	18.83 Part per billion (ppb) Geometric Coefficient of Variation 230.59	22.97 Part per billion (ppb) Geometric Coefficient of Variation 155.86	16.90 Part per billion (ppb) Geometric Coefficient of Variation 140.49	—	—	—
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Day 14 morning	18.17 Part per billion (ppb) Geometric Coefficient of Variation 213.64	23.17 Part per billion (ppb) Geometric Coefficient of Variation 204.29	25.06 Part per billion (ppb) Geometric Coefficient of Variation 168.79	31.32 Part per billion (ppb) Geometric Coefficient of Variation 183.61	—	—	—
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Day 28 morning	19.07 Part per billion (ppb) Geometric Coefficient of Variation 143.18	16.31 Part per billion (ppb) Geometric Coefficient of Variation 170.18	20.06 Part per billion (ppb) Geometric Coefficient of Variation 289.93	16.50 Part per billion (ppb) Geometric Coefficient of Variation 148.92	—	—	—
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) Average change from baseline over the treatment period	10.23 Part per billion (ppb) Geometric Coefficient of Variation 164.24	16.37 Part per billion (ppb) Geometric Coefficient of Variation 183.76	20.78 Part per billion (ppb) Geometric Coefficient of Variation 111.33	14.60 Part per billion (ppb) Geometric Coefficient of Variation 127.31	—	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The immunogenicity set included all participants in the safety set with at least one post-treatment ADA result (positive or negative). Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. Participants in the Part 1: Placebo arm did not have any post-treatment ADA results and were excluded from analysis.

ADA-positive samples were tested to investigate the immunogenicity of AZD1402.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo n=6 Participants Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers ADA positive at baseline and/or post-baseline (ADA prevalence)	1280.0 Titer Interval 160.0 to 5120.0	360.0 Titer Interval 40.0 to 1280.0	320.0 Titer Interval 240.0 to 800.0	—	240.0 Titer Interval 90.0 to 800.0	400.0 Titer Interval 160.0 to 2560.0	—
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers TE-ADA positive (ADA incidence)	1280.0 Titer Interval 160.0 to 5120.0	360.0 Titer Interval 40.0 to 1280.0	320.0 Titer Interval 240.0 to 800.0	—	240.0 Titer Interval 90.0 to 800.0	400 Titer Interval 160.0 to 2560.0	—
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers Treatment-induced ADA positive	1280.0 Titer Interval 160.0 to 5120.0	360.0 Titer Interval 40.0 to 1280.0	320.0 Titer Interval 240.0 to 800.0	—	240.0 Titer Interval 90.0 to 800.0	400 Titer Interval 160.0 to 2560.0	—
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers ADA persistently positive	1280.0 Titer Interval 160.0 to 5120.0	640.0 Titer Interval 80.0 to 1280.0	320.0 Titer Interval 240.0 to 800.0	—	—	240.0 Titer Interval 90.0 to 800.0	400.0 Titer Interval 160.0 to 2560.0
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers ADA transiently positive	—	NA Titer Values are not calculated due to insufficient number of participants with events.	—	—	—	—	—
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers TE-ADA positive with maximum titre > median of maximum titres	3840.0 Titer Interval 1280.0 to 5120.0	1280.0 Titer Interval 640.0 to 1280.0	NA Titer Values are not calculated due to insufficient number of participants with events.	—	NA Titer Values are not calculated due to insufficient number of participants with events.	2560.0 Titer Interval 640.0 to 2560.9	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The pharmacokinetic (PK) profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Maximum Observed Serum (Peak) Drug Concentration (Cmax) Day 1	NA Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation NA Values are not calculated due to insufficient number of participants with data.	2.745 Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation 43.2	5.864 Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation 50.2	NA Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—
Part 1 and Part 2: Maximum Observed Serum (Peak) Drug Concentration (Cmax) Day 28	3.986 Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation 68.9	10.46 Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation 103.0	30.97 Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation 124.7	NA Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Nanograms Per Milliliter (ng/mL) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) Day 1	—	NA Hours (h) Geometric Coefficient of Variation NA Values are not calculated due to insufficient number of participants with data.	9.440 Hours (h) Geometric Coefficient of Variation 49.4	NA Hours (h) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Hours (h) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—
Part 1 and Part 2: Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) Day 28	20.17 Hours (h) Geometric Coefficient of Variation 668.7	7.669 Hours (h) Geometric Coefficient of Variation 33.2	8.546 Hours (h) Geometric Coefficient of Variation 34.5	NA Hours (h) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Hours (h) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ) Day 28	46.75 h*ng/mL Geometric Coefficient of Variation 63.3	92.80 h*ng/mL Geometric Coefficient of Variation 94.4	264.4 h*ng/mL Geometric Coefficient of Variation 132.7	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—
Part 1 and Part 2: Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ) Day 1	—	23.15 h*ng/mL Geometric Coefficient of Variation 28.9	46.34 h*ng/mL Geometric Coefficient of Variation 52.4	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast) Day 1	—	16.32 h*ng/mL Geometric Coefficient of Variation 57.8	44.40 h*ng/mL Geometric Coefficient of Variation 56.9	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—
Part 1 and Part 2: Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast) Day 28	44.26 h*ng/mL Geometric Coefficient of Variation 604.9	146.3 h*ng/mL Geometric Coefficient of Variation 144.7	379.4 h*ng/mL Geometric Coefficient of Variation 169.6	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA h*ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Observed Lowest Drug Concentration Reached Before the Next Dose is Administered (Pre-dose) (Ctrough) Day 1	—	1.702 ng/mL Geometric Coefficient of Variation 30.0	2.917 ng/mL Geometric Coefficient of Variation 53.6	NA ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—
Part 1 and Part 2: Observed Lowest Drug Concentration Reached Before the Next Dose is Administered (Pre-dose) (Ctrough) Day 28	2.854 ng/mL Geometric Coefficient of Variation 66.3	5.145 ng/mL Geometric Coefficient of Variation 96.8	13.83 ng/mL Geometric Coefficient of Variation 144.2	NA ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA ng/mL Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz) Day 1	—	NA 1/hour Geometric Coefficient of Variation NA Values are not calculated due to insufficient number of participants with data.	0.07343 1/hour Geometric Coefficient of Variation 49.4	NA 1/hour Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA 1/hour Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—
Part 1 and Part 2: Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz) Day 28	0.03437 1/hour Geometric Coefficient of Variation 668.7	0.09040 1/hour Geometric Coefficient of Variation 33.2	0.08111 1/hour Geometric Coefficient of Variation 34.5	NA 1/hour Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA 1/hour Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)	622.5 Liters Geometric Coefficient of Variation 1007.5	322.9 Liters Geometric Coefficient of Variation 109.7	466.3 Liters Geometric Coefficient of Variation 172.0	NA Liters Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Liters Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=10 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)	21.39 Liters/hour (L/h) Geometric Coefficient of Variation 63.3	32.33 Liters/hour (L/h) Geometric Coefficient of Variation 94.4	37.82 Liters/hour (L/h) Geometric Coefficient of Variation 132.7	NA Liters/hour (L/h) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Liters/hour (L/h) Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=1 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=2 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax) Day 1	NA Hours Interval 3.0 to 6.0 Values are not calculated due to insufficient number of participants with data.	3.000 Hours Interval 2.0 to 8.0	4.017 Hours Interval 3.02 to 8.02	—	NA Hours Interval 3.05 to 3.05 Values are not calculated due to insufficient number of participants with data.	—	—
Part 1 and Part 2: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax) Day 28	3.025 Hours Interval 1.0 to 4.0	3.000 Hours Interval 0.0 to 6.0	3.950 Hours Interval 3.0 to 6.27	NA Hours Interval 5.93 to 5.93 Values are not calculated due to insufficient number of participants with data.	NA Hours Interval 7.67 to 8.07 Values are not calculated due to insufficient number of participants with data.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=11 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=1 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=2 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Time of Last Observed (Quantifiable) Concentration (Tlast) Day 1	NA Hours Interval 3.0 to 8.0 Values are not calculated due to insufficient number of participants with data.	8.000 Hours Interval 2.0 to 12.0	11.47 Hours Interval 8.18 to 12.0	—	NA Hours Interval 6.97 to 6.97 Values are not calculated due to insufficient number of participants with data.	—	—
Part 1 and Part 2: Time of Last Observed (Quantifiable) Concentration (Tlast) Day 28	11.99 Hours Interval 3.0 to 576.0	17.83 Hours Interval 12.0 to 48.2	23.94 Hours Interval 12.0 to 47.9	NA Hours Interval 5.93 to 5.93 Values are not calculated due to insufficient number of participants with data.	NA Hours Interval 7.67 to 22.8 Values are not calculated due to insufficient number of participants with data.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=1 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=3 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Accumulation Ratio for AUCτ (Rac AUC)	NA Ratio Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Ratio Geometric Coefficient of Variation NA Values are not calculated due to insufficient number of participants with data.	6.059 Ratio Geometric Coefficient of Variation 68.5	NA Ratio Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Ratio Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Day 1 until Day 56

Population: The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The PK profile of AZD1402 was investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=2 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=6 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=8 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=4 Participants Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=7 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 1 and Part 2: Accumulation Ratio for Cmax (Rac Cmax)	NA Ratio Geometric Coefficient of Variation NA Values are not calculated due to insufficient number of participants with data.	3.219 Ratio Geometric Coefficient of Variation 121.9	6.067 Ratio Geometric Coefficient of Variation 78.9	NA Ratio Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	NA Ratio Geometric Coefficient of Variation NA Values below the lower limit of quantification are not calculated.	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The efficacy of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA was further investigated. The ACQ was developed to measure asthma control. In the ACQ-6, participants were asked to recall how their asthma had been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated a worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) at Week 4 and Average Over the Treatment Period Change from baseline at Week 4	-0.80 Score on scale Standard Deviation 0.37	-0.71 Score on scale Standard Deviation 0.68	-0.56 Score on scale Standard Deviation 0.75	—	—	—	—
Part 2: Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) at Week 4 and Average Over the Treatment Period Average change from baseline over treatment period	-0.75 Score on scale Standard Deviation 0.56	-0.78 Score on scale Standard Deviation 0.33	-0.56 Score on scale Standard Deviation 0.66	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The efficacy of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA was further investigated. The ACQ was developed to measure asthma control. In the ACQ-6, participants were asked to recall how their asthma had been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated a worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Participants With a Decrease in ACQ 6 Score of ≥ 0.5 From Baseline to Week 4 Responder	3 Participants	7 Participants	3 Participants	—	—	—	—
Part 2: Participants With a Decrease in ACQ 6 Score of ≥ 0.5 From Baseline to Week 4 Non-responder	1 Participants	2 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Peak expiratory flow was measured by the participants at home using a peak flow meter.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period Change from baseline at Week 4	23.73 Liters/minute (L/m) Standard Deviation 15.24	19.88 Liters/minute (L/m) Standard Deviation 47.38	-2.53 Liters/minute (L/m) Standard Deviation 26.69	—	—	—	—
Part 2: Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period Average change from baseline over the treatment period	20.67 Liters/minute (L/m) Standard Deviation 8.58	21.40 Liters/minute (L/m) Standard Deviation 37.83	-5.54 Liters/minute (L/m) Standard Deviation 24.17	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Peak expiratory flow was measured by the participants at home using a peak flow meter.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in Average Evening PEF Over the Treatment Period Average change from baseline over the treatment period	14.20 Liters/minute (L/m) Standard Deviation 10.37	-7.75 Liters/minute (L/m) Standard Deviation 25.79	1.87 Liters/minute (L/m) Standard Deviation 19.27	—	—	—	—
Part 2: Change From Baseline in Average Evening PEF Over the Treatment Period Change from baseline at Week 4	18.68 Liters/minute (L/m) Standard Deviation 3.94	-15.81 Liters/minute (L/m) Standard Deviation 28.63	0.89 Liters/minute (L/m) Standard Deviation 30.22	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Severity scores for asthma symptoms were recorded twice daily in the morning and evening and documented in an e-Diary. Asthma symptom scores during night-time and day-time were assessed by the participant each morning and evening according to the following scoring system: 0: You have no asthma symptoms. 1: You are aware of your asthma symptoms but you can easily tolerate the symptoms. 2: Your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep). 3: You are unable to do your normal activities (or to sleep) because of your asthma. Higher scores indicated worse outcome.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in Daily Average Asthma Symptom Score (AM/PM) Over the Treatment Period Change from baseline at Week 4	-0.23 Score on scale Standard Deviation 0.26	0.07 Score on scale Standard Deviation 0.26	-0.04 Score on scale Standard Deviation 0.37	—	—	—	—
Part 2: Change From Baseline in Daily Average Asthma Symptom Score (AM/PM) Over the Treatment Period Average change from baseline over the treatment period	-0.10 Score on scale Standard Deviation 0.27	0.02 Score on scale Standard Deviation 0.22	-0.07 Score on scale Standard Deviation 0.32	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period Week 4	0.0095 Liters (L) Standard Error 0.1085	0.1500 Liters (L) Standard Error 0.1898	-0.0252 Liters (L) Standard Error 0.1754	—	—	—	—
Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period Week 1	0.0233 Liters (L) Standard Error 0.0526	0.1408 Liters (L) Standard Error 0.1679	0.0101 Liters (L) Standard Error 0.1094	—	—	—	—
Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period Week 2	0.0028 Liters (L) Standard Error 0.0618	0.0866 Liters (L) Standard Error 0.1607	0.1671 Liters (L) Standard Error 0.3323	—	—	—	—
Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period Week 3	0.0160 Liters (L) Standard Error 0.1140	0.0431 Liters (L) Standard Error 0.1676	0.1099 Liters (L) Standard Error 0.1583	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The effect of AZD1402 compared to placebo on airway inflammation in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO was performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation were followed such that plateau definition could be evaluated over a minimum of 3 seconds.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Change From Baseline in FeNO (In-clinic) at Week 4 and Average Over the Treatment Period Average change from baseline over the treatment period	32.02 Parts per billion (ppb) Geometric Coefficient of Variation 153.61	14.16 Parts per billion (ppb) Geometric Coefficient of Variation 343.96	27.45 Parts per billion (ppb) Geometric Coefficient of Variation 102.83	—	—	—	—
Part 2: Change From Baseline in FeNO (In-clinic) at Week 4 and Average Over the Treatment Period Change from baseline at Week 4	39.77 Parts per billion (ppb) Geometric Coefficient of Variation 55.03	28.76 Parts per billion (ppb) Geometric Coefficient of Variation 91.99	31.20 Parts per billion (ppb) Geometric Coefficient of Variation 122.50	—	—	—	—

SECONDARY outcome

Timeframe: From Screening (Week -6) until Follow-up (Day 56)

Population: The safety set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints.

The safety and tolerability of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was evaluated.

Outcome measures

Measure	Part 1: AZD1402 Dose 1 n=4 Participants Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=9 Participants Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo Randomised participants received oral inhalation of matching placebo via DPI.
Part 2: Number of Participants With Adverse Events (AEs) Any AE leading to withdrawal from study	0 Participants	0 Participants	0 Participants	—	—	—	—
Part 2: Number of Participants With Adverse Events (AEs) Any AE	3 Participants	5 Participants	6 Participants	—	—	—	—
Part 2: Number of Participants With Adverse Events (AEs) Any SAE	0 Participants	1 Participants	0 Participants	—	—	—	—
Part 2: Number of Participants With Adverse Events (AEs) Any SAE with outcome death	0 Participants	0 Participants	0 Participants	—	—	—	—
Part 2: Number of Participants With Adverse Events (AEs) Any AE leading to discontinuation of IP	0 Participants	0 Participants	0 Participants	—	—	—	—

Adverse Events

Part 1: AZD1402 Dose 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: AZD1402 Dose 2

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1: AZD1402 Dose 3

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 1: Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2: AZD1402 Dose 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: AZD1402 Dose 2

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: AZD1402 Dose 1 n=11 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 participants at risk Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=4 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 n=9 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo n=9 participants at risk Randomised participants received oral inhalation of matching placebo via DPI.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)

Other adverse events

Measure	Part 1: AZD1402 Dose 1 n=11 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 1: AZD1402 Dose 2 n=10 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 1: AZD1402 Dose 3 n=13 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI.	Part 1: Placebo n=16 participants at risk Randomised participants received oral inhalation of matching placebo via DPI.	Part 2: AZD1402 Dose 1 n=4 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI.	Part 2: AZD1402 Dose 2 n=9 participants at risk Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI.	Part 2: Placebo n=9 participants at risk Randomised participants received oral inhalation of matching placebo via DPI.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Injury, poisoning and procedural complications Limb injury	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Injury, poisoning and procedural complications Bone contusion	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Injury, poisoning and procedural complications Skin laceration	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
General disorders Fatigue	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	6.2% 1/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
General disorders Pyrexia	18.2% 2/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Renal and urinary disorders Leukocyturia	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Investigations C-reactive protein increased	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Investigations Forced expiratory volume decreased	18.2% 2/11 • From Screening (Week -6) until Follow-up (Day 56)	30.0% 3/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	6.2% 1/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Investigations Transaminases	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	10.0% 1/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Investigations Alanine aminotransferase increased	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Infections and infestations Covid-19	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	10.0% 1/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	6.2% 1/16 • From Screening (Week -6) until Follow-up (Day 56)	25.0% 1/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Infections and infestations Gastroenteritis	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Infections and infestations Nasopharyngitis	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	18.8% 3/16 • From Screening (Week -6) until Follow-up (Day 56)	25.0% 1/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Infections and infestations Oral candidiasis	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Nervous system disorders Dysaesthesia	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Nervous system disorders Headache	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	38.5% 5/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	25.0% 1/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Nervous system disorders Tension headache	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Eye disorders Conjuctivitis allergic	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	15.4% 2/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Ear and labyrinth disorders Ear haemorrhage	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	22.2% 2/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	20.0% 2/10 • From Screening (Week -6) until Follow-up (Day 56)	30.8% 4/13 • From Screening (Week -6) until Follow-up (Day 56)	18.8% 3/16 • From Screening (Week -6) until Follow-up (Day 56)	25.0% 1/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	44.4% 4/9 • From Screening (Week -6) until Follow-up (Day 56)
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.2% 2/11 • From Screening (Week -6) until Follow-up (Day 56)	10.0% 1/10 • From Screening (Week -6) until Follow-up (Day 56)	38.5% 5/13 • From Screening (Week -6) until Follow-up (Day 56)	12.5% 2/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	22.2% 2/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	10.0% 1/10 • From Screening (Week -6) until Follow-up (Day 56)	15.4% 2/13 • From Screening (Week -6) until Follow-up (Day 56)	18.8% 3/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Gastrointestinal disorders Nausea	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Gastrointestinal disorders Umbilical hernia	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)
Gastrointestinal disorders Vomiting	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	11.1% 1/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	23.1% 3/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	7.7% 1/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/10 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/13 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/16 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/4 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)	0.00% 0/9 • From Screening (Week -6) until Follow-up (Day 56)

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
• Publication restrictions are in place

Restriction type: OTHER