AZD9164 Single Ascending Dose study in Healthy Male Subjects
Study identifier:D1882C00001
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 AZD9164 after Single Ascending Doses in Healthy Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD9164, Placebo
Sex
Male
Actual Enrollment
65
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Feb 2009
Primary Completion Date: -
Study Completion Date: 01 Apr 2009
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: 1 Solution for nebulisation, inhaled | Drug: AZD9164 Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits. |
| Placebo Comparator: 2 Solution for nebulisation, inhaled | Drug: Placebo Each subject will receive a single-dose. |
Contacts
Investigators
Principal Investigator
Anders Luts
AstraZeneca
