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

NCT ID: NCT01166698

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers Safety Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD9819

Inhaled suspension

Group Type EXPERIMENTAL

AZD9819

Intervention Type DRUG

Inhaled single doses of suspension via SPIRA nebuliser

AZD9819

Intervention Type DRUG

Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days

Placebo

Inhaled suspension

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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AZD9819

Inhaled single doses of suspension via SPIRA nebuliser

Intervention Type DRUG

AZD9819

Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Part B (multiple ascending doses) Part A and B

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D3020C00001

Identifier Type: -

Identifier Source: org_study_id