Adults 20 to 45, male only, with Asthma or Chronic Obstructive Pulmonary Disease COPD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability of AZD7594 by Assessment of the Number of Participants With Adverse EventsPrimary· At screening (Day -28, Day -02 and Day -1), Treatment period (Days 1 to 20) and Follow-up (Day 29).
To assess the safety and tolerability of single and multiple doses of AZD7594
Any AE
Group
Value
95% CI
AZD7594 200 μg
3
AZD7594 400 μg
1
AZD7594 1600 μg
1
Total AZD7594
5
Placebo
1
All Subjects
6
Any AE with outcome = death
Group
Value
95% CI
AZD7594 200 μg
0
AZD7594 400 μg
0
AZD7594 1600 μg
0
Total AZD7594
0
Placebo
0
All Subjects
0
Any SAE including events with outcome =death
Group
Value
95% CI
AZD7594 200 μg
0
AZD7594 400 μg
0
AZD7594 1600 μg
0
Total AZD7594
0
Placebo
0
All Subjects
0
Any AE leading to discontinuation of IP
Group
Value
95% CI
AZD7594 200 μg
0
AZD7594 400 μg
0
AZD7594 1600 μg
0
Total AZD7594
0
Placebo
0
All Subjects
0
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Observed Maximum Plasma Concentration (Cmax)Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.
Assessment of the plasma PK following a single dose of AZD7594.
Cmax was defined as observed maximum plasma concentration, taken directly from the individual concentration-time curve.
Group
Value
95% CI
AZD7594 200 μg
56.05
± 22.0
AZD7594 400 μg
76.93
± 34.4
AZD7594 1600 μg
430.8
± 22.4
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.
Assessment of the plasma PK following a single dose of AZD7594.
tmax was defined as time to reach maximum plasma concentration, taken directly from the individual concentration-time curve.
Group
Value
95% CI
AZD7594 200 μg
0.25
0.25 – 0.98
AZD7594 400 μg
0.52
0.25 – 3.00
AZD7594 1600 μg
0.50
0.25 – 4.00
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC [0-last])Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
AUC (0-last) was defined as the area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration.
Group
Value
95% CI
AZD7594 200 μg
1314
± 28.2
AZD7594 400 μg
2736
± 12.2
AZD7594 1600 μg
13960
± 18.2
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero to 24 Hours After Dosing (AUC [0-24]).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
AUC (0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing.
Group
Value
95% CI
AZD7594 200 μg
681.1
± 11.5
AZD7594 400 μg
1084
± 19.4
AZD7594 1600 μg
6060
± 18.4
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero Extrapolated to Infinity (AUC).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
AUC was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUC(0-last) + Clast/λz where Clast is the last observed quantifiable concentration.
NOTE: No results were available for participants belonging to AZD7594 2ug and AZD7594 400ug groups.
Group
Value
95% CI
AZD7594 200 μg
NA
± NA
AZD7594 400 μg
NA
± NA
AZD7594 1600 μg
18260
± 22.9
Rate and Extent of Absorption of AZD7594 by Assessment of the Terminal Elimination Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve(Lamda z or λz).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
λz was defined as terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve.
Group
Value
95% CI
AZD7594 200 μg
0.015573
± 24.5
AZD7594 400 μg
0.011058
± 18.3
AZD7594 1600 μg
0.013862
± 21.4
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Half-life Associated With the Terminal Slope of a Semi-logarithmic Concentration-time Curve (t1/2λz).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.
NOTE: No results were available for participants belonging to AZD7594 400ug group.
Group
Value
95% CI
AZD7594 200 μg
39.88
± 5.441
AZD7594 400 μg
NA
± NA
AZD7594 1600 μg
43.57
± 3.815
Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Mean Residence Time From Time Zero Extrapolated to Infinity (MRT).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
MRT was defined as Mean residence time from time zero extrapolated to infinity.
NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.
Group
Value
95% CI
AZD7594 200 μg
NA
± NA
AZD7594 400 μg
NA
± NA
AZD7594 1600 μg
65.03
± 4.7
Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (AZD7594) (CL/F).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.
Assessment of the plasma PK following a single dose of AZD7594.
CL/F was defined as apparent total body clearance after extravascular administration estimated as dose divided by AUC (AZD7594).
NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.
Group
Value
95% CI
AZD7594 200 μg
NA
± NA
AZD7594 400 μg
NA
± NA
AZD7594 1600 μg
144.5
± 22.9
Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration, Estimated by Dividing CL/F by Lamda z (Vz/F)Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.
Assessment of the plasma PK following a single dose of AZD7594.
Vz/F was defined as apparent volume of distribution during the terminal phase after extravascular administration, estimated by dividing the apparent clearance (CL/F) by λz.
NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.
Group
Value
95% CI
AZD7594 200 μg
NA
± NA
AZD7594 400 μg
NA
± NA
AZD7594 1600 μg
9297
± 24.1
Rate and Extent of Absorption of AZD7594 by Assessment of the Cmax Divided by the Dose Administered (Cmax/D).Secondary· Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Assessment of the plasma PK following a single dose of AZD7594.
Cmax/D was defined as observed maximum plasma concentration divided by the dose administered.
Group
Value
95% CI
AZD7594 200 μg
169.9
± 22.0
AZD7594 400 μg
116.7
± 34.4
AZD7594 1600 μg
163.2
± 22.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs) were recorded from the signing of informed consent and adverse events (AEs) were recorded from randomization until the final follow-up visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 19 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02645253.