AZD5423 Single Ascending Dose Study
Study identifier:D2340C00001
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 Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD5423 after Single Ascending Doses in Healthy Male Subjects
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5423, Placebo
Sex
Male
Actual Enrollment
72
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: 01 Nov 2009
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A Drug: AZD5423 | Drug: AZD5423 Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits. |
| Placebo Comparator: B Drug: Placebo | Drug: Placebo Solution for nebulisation, inhaled. Each subject will receive a single-dose. |
Contacts
Investigators
Principal Investigator
Jorup Carin
AstraZeneca R&D, Lund, Sweden
