Trial Outcomes & Findings for To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration (NCT NCT02679729)

Results Overview

To assess the safety and tolerability of AZD5634 in terms of number of participants following inhaled administration of single-ascending doses (SAD) (Part A) and following administration of single inhaled and IV doses (Part B)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

63 participants

Primary outcome timeframe

Screening (serious adverse event, SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.

Results posted on

2018-11-05

Participant Flow

Phase 1, first-in-human (FIH), single-blind, placebo-controlled, single ascending dose (SAD), sequential dose group study in healthy male participants and female participants of non-childbearing potential at 2 study centers (EPCU Baltimore and EPCU Los Angeles). The study comprised of Part A and Part B.

The study consisted of a screening period (Days -28 to -1).

Participant milestones

Participant milestones
Measure	Part A - AZD5634 - 10 μg Participants received inhaled single doses of AZD5634 10 μg under fasted conditions	Part A - AZD5634 27 μg Participants received inhaled single doses of AZD5634 27 μg under fasted conditions	Part A - AZD5634 81 μg Participants received inhaled single doses of AZD5634 81 μg under fasted conditions	Part A - AZD5634 216 μg Participants received inhaled single doses of AZD5634 216 μg under fasted conditions	Part A - AZD5634 648 μg Participants received inhaled single doses of AZD5634 648 μg under fasted conditions	Part A - AZD5634 1296 μg Participants received inhaled single doses of AZD5634 1296 μg under fasted conditions	Part A - AZD5634 1692 μg Participants received inhaled single doses of AZD5634 1692 μg under fasted conditions	Part A - Placebo 2 participants per dose level received single dose of placebo in Part A	PartB- AZD5634-Intravenous(IV) 65μg and Inhalation(IN) 1692μg After safety evaluation of all inhaled AZD5634 cohorts, 6 participants (who did not participate in Part A) were admitted for inhaled (1692 μg AZD5634) and IV (65 μg AZD5634) dosing (fixed dosing; IV first followed by inhalation), with at least a 14 day washout between dosing
Overall Study STARTED	6	7	6	6	6	6	6	14	6
Overall Study COMPLETED	6	5	6	6	5	6	5	14	6
Overall Study NOT COMPLETED	0	2	0	0	1	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - AZD5634 - 10 μg Participants received inhaled single doses of AZD5634 10 μg under fasted conditions	Part A - AZD5634 27 μg Participants received inhaled single doses of AZD5634 27 μg under fasted conditions	Part A - AZD5634 81 μg Participants received inhaled single doses of AZD5634 81 μg under fasted conditions	Part A - AZD5634 216 μg Participants received inhaled single doses of AZD5634 216 μg under fasted conditions	Part A - AZD5634 648 μg Participants received inhaled single doses of AZD5634 648 μg under fasted conditions	Part A - AZD5634 1296 μg Participants received inhaled single doses of AZD5634 1296 μg under fasted conditions	Part A - AZD5634 1692 μg Participants received inhaled single doses of AZD5634 1692 μg under fasted conditions	Part A - Placebo 2 participants per dose level received single dose of placebo in Part A	PartB- AZD5634-Intravenous(IV) 65μg and Inhalation(IN) 1692μg After safety evaluation of all inhaled AZD5634 cohorts, 6 participants (who did not participate in Part A) were admitted for inhaled (1692 μg AZD5634) and IV (65 μg AZD5634) dosing (fixed dosing; IV first followed by inhalation), with at least a 14 day washout between dosing
Overall Study Lost to Follow-up	0	1	0	0	1	0	0	0	0
Overall Study Participant decision	0	1	0	0	0	0	1	0	0

Baseline Characteristics

Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD5634 - Inhaled 10 μg n=6 Participants Participants received inhaled single doses of AZD5634 10 μg under fasted conditions	AZD5634 27 μg n=7 Participants Participants received inhaled single doses of AZD5634 27 μg under fasted conditions	AZD5634 81 μg n=6 Participants Participants received inhaled single doses of AZD5634 81 μg under fasted conditions	AZD5634 216 μg n=6 Participants Participants received inhaled single doses of AZD5634 216 μg under fasted conditions	AZD5634 648 μg n=6 Participants Participants received inhaled single doses of AZD5634 648 μg under fasted conditions	AZD5634 1296 μg n=6 Participants Participants received inhaled single doses of AZD5634 1296 μg under fasted conditions	AZD5634 1692 μg n=6 Participants Participants received inhaled single doses of AZD5634 1692 μg under fasted conditions	Placebo n=14 Participants 2 participants per dose level received single dose of placebo in Part A	AZD5634 - IV 65 μg and IN 1692 μg n=6 Participants After safety evaluation of all inhaled AZD5634 cohorts, 6 participants (who did not participate in Part A) were admitted for inhaled (1692 μg AZD5634) and IV (65 μg AZD5634) dosing (fixed dosing; IV first followed by inhalation), with at least a 14 day washout between dosing	Total n=63 Participants Total of all reporting groups
Age, Continuous Part A	36.5 Years STANDARD_DEVIATION 12.2 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	33.3 Years STANDARD_DEVIATION 9.3 • n=7 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	31.8 Years STANDARD_DEVIATION 3.4 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	32.0 Years STANDARD_DEVIATION 6.9 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	37.7 Years STANDARD_DEVIATION 9.1 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	31.7 Years STANDARD_DEVIATION 5.2 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	35.2 Years STANDARD_DEVIATION 10.6 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	32.6 Years STANDARD_DEVIATION 8.9 • n=14 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	—	34.0 Years STANDARD_DEVIATION 8.3 • n=57 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63
Age, Continuous Part B	—	—	—	—	—	—	—	—	32.0 Years STANDARD_DEVIATION 7.9 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63	32.0 Years STANDARD_DEVIATION 7.9 • n=6 Participants • Data for Part A and Part B are presented in separate rows. Part A and Part B data when added (57 + 6) will give the overall total of 63
Sex: Female, Male Female	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=14 Participants	0 Participants n=6 Participants	3 Participants n=63 Participants
Sex: Female, Male Male	6 Participants n=6 Participants	7 Participants n=7 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	13 Participants n=14 Participants	6 Participants n=6 Participants	60 Participants n=63 Participants

PRIMARY outcome

Timeframe: Screening (serious adverse event, SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.

Population: All partcipants in safety analysis set who received at least 1 dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.

To assess the safety and tolerability of AZD5634 in terms of number of participants following inhaled administration of single-ascending doses (SAD) (Part A) and following administration of single inhaled and IV doses (Part B)

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=6 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=7 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=6 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=6 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 n=14 Participants 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg n=6 Participants Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg n=6 Participants Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Safety and Tolerability of AZD5634 Following Inhaled Administration of Single-ascending Doses (SAD) (Part A) and Following Administration of Single Inhaled and IV Doses (Part B). Any AE during treatment	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	3 Participants	2 Participants	1 Participants
Safety and Tolerability of AZD5634 Following Inhaled Administration of Single-ascending Doses (SAD) (Part A) and Following Administration of Single Inhaled and IV Doses (Part B). Any AE with outcome = death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of AZD5634 Following Inhaled Administration of Single-ascending Doses (SAD) (Part A) and Following Administration of Single Inhaled and IV Doses (Part B). Any SAE (including events with outcome = death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of AZD5634 Following Inhaled Administration of Single-ascending Doses (SAD) (Part A) and Following Administration of Single Inhaled and IV Doses (Part B). Any AE during Follow-up	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic (PK) parameter Cmax of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Observed Maximum Plasma Concentration, Taken Directly From the Individual Concentration-time Curve (Cmax)- For Part A and Part B	0.01605 nmol/L Geometric Coefficient of Variation 18.8	0.04581 nmol/L Geometric Coefficient of Variation 45.2	0.2977 nmol/L Geometric Coefficient of Variation 20.0	0.3043 nmol/L Geometric Coefficient of Variation 46.5	0.5316 nmol/L Geometric Coefficient of Variation 51.6	6.070 nmol/L Geometric Coefficient of Variation 8.9	0.3808 nmol/L Geometric Coefficient of Variation 34.7	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter AUC of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. AUC was estimated by AUC(0-last) + Clast/λz where Clast was the last observed quantifiable concentration. AUCs were calculated using the linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. AUC0-t is expanded as area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. Note:Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Area Under Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part A and Part B	NA h*nmol/L Geometric Coefficient of Variation NA Due to the participant and/or data exclusion, data were not available	0.1757 h*nmol/L Geometric Coefficient of Variation 34.9	1.258 h*nmol/L Geometric Coefficient of Variation 16.7	1.299 h*nmol/L Geometric Coefficient of Variation 57.2	2.837 h*nmol/L Geometric Coefficient of Variation 71.5	2.329 h*nmol/L Geometric Coefficient of Variation 11.3	1.777 h*nmol/L Geometric Coefficient of Variation 37.2	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter AUC(0-t) of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)] for Part A and Part B	0.01920 h*nmol/L Geometric Coefficient of Variation 60.1	0.1120 h*nmol/L Geometric Coefficient of Variation 62.2	1.301 h*nmol/L Geometric Coefficient of Variation 22.0	1.244 h*nmol/L Geometric Coefficient of Variation 57.2	2.664 h*nmol/L Geometric Coefficient of Variation 60.9	2.318 h*nmol/L Geometric Coefficient of Variation 11.4	1.831 h*nmol/L Geometric Coefficient of Variation 38.0	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the Absolute systemic bioavailability after inhalation (%), calculated separately as 100\*AUCinhalation\*Doseiv/(AUCiv\*Doseinhalation)

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=6 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=6 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Absolute Systemic Bioavailability After Inhalation (Part B Only) (Finhalation,Total)	NA Percentage of bioavailable dose Geometric Coefficient of Variation NA Due to the participant and/or data exclusion, data were not available	2.928 Percentage of bioavailable dose Geometric Coefficient of Variation 42.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: -12-0, 0-6, 6-12, 12-24, 24-48 h (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter CLR of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Renal Clearance (CLR), Estimated by Dividing Ae(0-last) by AUC0-t - For Part A and Part B	1.449 L/h Standard Deviation 0.1332	0.8099 L/h Standard Deviation 0.2849	0.5828 L/h Standard Deviation 0.1724	0.9063 L/h Standard Deviation 0.2459	0.7333 L/h Standard Deviation 0.1893	0.6247 L/h Standard Deviation 0.3373	0.6939 L/h Standard Deviation 0.1044	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter Cmax/Dose of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Cmax, Divided by the Dose Aministered (Cmax/Dose) - For Part A and Part B	0.1473 nmol/L/umol Geometric Coefficient of Variation 18.8	0.1576 nmol/L/umol Geometric Coefficient of Variation 45.2	0.3415 nmol/L/umol Geometric Coefficient of Variation 20.0	0.1745 nmol/L/umol Geometric Coefficient of Variation 46.5	0.2335 nmol/L/umol Geometric Coefficient of Variation 51.6	69.41 nmol/L/umol Geometric Coefficient of Variation 8.9	0.1673 nmol/L/umol Geometric Coefficient of Variation 34.7	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter t1/2λz of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Terminal Half-life (t1/2λz), Estimated as (ln2)/λz - For Part A and Part B	NA Hours Standard Deviation NA Due to the participant and/or data exclusion, data were not available	1.519 Hours Standard Deviation 0.1499	1.903 Hours Standard Deviation 0.4722	3.144 Hours Standard Deviation 2.250	7.552 Hours Standard Deviation 5.438	0.1923 Hours Standard Deviation 0.05567	3.184 Hours Standard Deviation 1.816	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter AUC0-t/Dose of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
AUC0-t, Divided by the Dose Administered (AUC0-t/Dose) - For Part A and Part B	0.1762 h*nmol/L/umol Geometric Coefficient of Variation 60.1	0.3856 h*nmol/L/umol Geometric Coefficient of Variation 62.2	1.492 h*nmol/L/umol Geometric Coefficient of Variation 22.0	0.7137 h*nmol/L/umol Geometric Coefficient of Variation 57.2	1.170 h*nmol/L/umol Geometric Coefficient of Variation 60.9	26.51 h*nmol/L/umol Geometric Coefficient of Variation 11.4	0.8044 h*nmol/L/umol Geometric Coefficient of Variation 38.0	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter AUC/Dose of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
AUC, Divided by the Dose Administered (AUC/Dose) - For Part A and Part B	NA h*nmol/L/umol Geometric Coefficient of Variation NA Due to the participant and/or data exclusion, data were not available	0.6046 h*nmol/L/umol Geometric Coefficient of Variation 34.9	1.444 h*nmol/L/umol Geometric Coefficient of Variation 16.7	0.7450 h*nmol/L/umol Geometric Coefficient of Variation 57.2	1.246 h*nmol/L/umol Geometric Coefficient of Variation 71.5	26.63 h*nmol/L/umol Geometric Coefficient of Variation 11.3	0.7805 h*nmol/L/umol Geometric Coefficient of Variation 37.2	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter CL of AZD5634 following single-dose IV administration of AZD5634 in Part B

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=6 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Systemic Clearance for AZD5634 Estimated as Dose Divided by AUC (Part B IV Dosing Only) (CL)	37.74 L/h Standard Deviation 4.220	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter CL/F of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Apparent Clearance for AZD5634 Estimated as Dose Divided by AUC (Part A and Part B Inhaled Dosing Only) (CL/F)	NA L/h Standard Deviation NA Due to the participant and/or data exclusion, data were not available	1727 L/h Standard Deviation 589.7	699.9 L/h Standard Deviation 115.3	1518 L/h Standard Deviation 852.7	929.8 L/h Standard Deviation 548.2	1346 L/h Standard Deviation 457.8	—	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter MRT of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 Participants Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Mean Residence Time (MRT) - For Part A and Part B	NA hour Standard Deviation NA Due to the participant and/or data exclusion, data were not available	2.742 hour Standard Deviation 0.1741	3.529 hour Standard Deviation 0.5093	4.157 hour Standard Deviation 1.166	6.000 hour Standard Deviation 2.009	0.1928 hour Standard Deviation 0.02455	4.428 hour Standard Deviation 1.293	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter MAT of AZD5634 following single-dose IV or inhalation administration of AZD5634 in Part B

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=6 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=6 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Mean Absorption Time, Calculated as MRTinhaled - MRTIV (Part B Only) (MAT)	NA hour Standard Deviation NA This parameter analysis was not applicable for this arm.	4.236 hour Standard Deviation 1.302	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter Vss of AZD5634 following single-dose IV administration of AZD5634 in Part B

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=6 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Volume of Distribution for AZD5634 at Steady State (IV Administration), Estimated by Dividing the MRT by the Systemic CL (Part B IV Dosing Only) (Vss)	7.202 Litre Standard Deviation 0.3915	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter Vz of AZD5634 following single-dose IV administration of AZD5634 in Part B

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=6 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Volume of Distribution for AZD5634 at Terminal Phase (IV Administration), Estimated by Dividing the Systemic CL by λz (Part B IV Dosing Only) (Vz)	10.25 Litre Standard Deviation 1.804	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)

Population: The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the pharmacokinetic parameter Vz/F of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.

Outcome measures

Outcome measures
Measure	Part A - AZD5634 10 µg n=3 Participants Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=5 Participants Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=5 Participants Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 Participants Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=5 Participants Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 Participants Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg Participants received IV dose of AZD5634 65 µg	Part B - AZD5634 IN 1692 µg Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
Apparent Volume of Distribution for AZD5634 at Terminal Phase (Inhaled Administration), Estimated by Dividing the CL/F by λz (Part A and Part B Inhaled Dosing Only) (Vz/F)	NA Litre Standard Deviation NA Due to the participant and/or data exclusion, data were not available	3775 Litre Standard Deviation 1306	1864 Litre Standard Deviation 178.2	5416 Litre Standard Deviation 1905	7115 Litre Standard Deviation 2202	5361 Litre Standard Deviation 1077	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A - AZD5634 10 µg n=6 participants at risk Participants received inhaled single doses of AZD5634 10 µg under fasted conditions	Part A - AZD5634 27 µg n=7 participants at risk Participants received inhaled single doses of AZD5634 27 µg under fasted conditions	Part A - AZD5634 81 µg n=6 participants at risk Participants received inhaled single doses of AZD5634 81 µg under fasted conditions	Part A - AZD5634 216 µg n=6 participants at risk Participants received inhaled single doses of AZD5634 216 µg under fasted conditions	Part A - AZD5634 648 µg n=6 participants at risk Participants received inhaled single doses of AZD5634 648 µg under fasted conditions	Part A - AZD5634 1296 µg n=6 participants at risk Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions	Part A - AZD5634 1692 µg n=6 participants at risk Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions	Part A - Placebo for AZD5634 n=14 participants at risk 2 participants per dose level received single dose of placebo in Part A	Part B - AZD5634 IV 65 µg n=6 participants at risk Participants received IV dose of IV 65 µg	Part B - AZD5634 IN 1692 µg n=6 participants at risk Participants received IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
General disorders Medical device site dermatitis	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	33.3% 2/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Nervous system disorders Headache	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	7.1% 1/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Nervous system disorders Dizziness	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	7.1% 1/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Cardiac disorders Atrioventricular block second degree	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Gastrointestinal disorders Nausea	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	7.1% 1/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Infections and infestations Paronychia	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	7.1% 1/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Injury, poisoning and procedural complications Laceration	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	7.1% 1/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.
Infections and infestations Viral upper respiratory tract infection	16.7% 1/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/7 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/14 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.	0.00% 0/6 • Screening (SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.

Additional Information

Global Clinical Leader

AstraZeneca AB

Phone: +46 766 346712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential and property of the sponsor. No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB.
Publication restrictions are in place

Restriction type: OTHER