AZD9164 Single Ascending Dose Study in Healthy Male Subjects

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Single Ascending Doses in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00847249

Enrollment

Registered

2009-02-19

Start date

2009-02-28

Completion date

2009-04-30

Last updated

2009-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

safety, tolerability, healthy, inhalation, Healthy males

Brief summary

The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Interventions

DRUGAZD9164

Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

DRUGPlacebo

Each subject will receive a single-dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed, written and dated informed consent prior to any study specific procedures * Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg * Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion criteria

* Any clinically significant disease or disorder * Any clinically significant abnormalities at screening examinations * Use of any prescribed or non-prescribed medication

Design outcomes

Primary

Measure	Time frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	up to 48 hours post-dose.

Secondary

Measure	Time frame
Pharmacokinetics	up to 48 hours post-dose.
Local and extrapulmonary effects	up to 48 hours post-dose.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026