AZD5423 Multiple Ascending Dose study
Study identifier:D2340C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 after Administration of Multiple Ascending Doses for 14 days in Healthy Male and Female Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5423, Placebo
Sex
All
Actual Enrollment
27
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jan 2010
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
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 Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A Drug: AZD5423 | Drug: AZD5423 Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits. |
| Placebo Comparator: B Drug: Placebo | Drug: Placebo Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. |
Contacts
Investigators
Principal Investigator
Darren Wilbraham
Quintiles Drug Research Unit at Guy's Hospital, London, UK
