Study identifier:D3020C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Volunteers, Safety
Phase 1
Yes
AZD9819, Placebo
All
100
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
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 |
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