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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
