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

Study identifier:D3020C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy Volunteers, Safety

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9819, Placebo

Sex

All

Actual Enrollment

100

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Aug 2010

Primary Completion Date: 01 Jan 2011

Study Completion Date: 01 Jan 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

London, United Kingdom

Arms	Assigned Interventions
Experimental: AZD9819 Inhaled suspension	Drug: AZD9819 Inhaled single doses of suspension via SPIRA nebuliser Drug: AZD9819 Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days Other Name: Part B (multiple ascending doses)
Placebo Comparator: Placebo Inhaled suspension	Drug: Placebo Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B) Other Name: Part A and B

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1311&filename=CSR-D3020C00001.pdf
Download
CSR-D3020C00001.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Suresh Babu

+44 (0)20 7910 7877

suresh.babu@quintiles.com