Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01166698

Enrollment

100

Registered

2010-07-21

Start date

2010-08-31

Completion date

2011-01-31

Last updated

2011-11-09

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

Conditions

Healthy Volunteers, Safety, Tolerability

Keywords

Safety, tolerability, healthy, inhalation

Brief summary

The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.

Interventions

DRUGAZD9819

Inhaled single doses of suspension via SPIRA nebuliser

DRUGPlacebo

Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. * Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)	Frequent safety measurements during the study from screening period to follow-up

Secondary

Measure	Time frame
Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma	Multiple PK blood samples from pre-dose until 96 hours post last dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026