To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of inhaled AZD7594
Study identifier:D3740C00001
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, Pharmacokinetics and Pharmacodynamics After Single and Multiple Ascending Inhaled Doses of AZD7594 in Healthy Male Volunteers
Medical condition
Safety, Pharmacodynamics of AZD7594
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD7594, Placebo to match
Sex
Male
Actual Enrollment
175
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Sept 2012
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Jun 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 May 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Subjects will participate in 1 of up to 9 groups in Part A (single ascending dose part) or 1 of 4 groups in Part B (multiple ascending dose part). Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B. | Drug: AZD7594 Suspension inhaled via Spira nebuliser |
| Placebo Comparator: 2 Subjects will participate in 1 of up to 9 groups in Part A or 1 of 4 groups in Part B. Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B. | Drug: Placebo to match Matching placebo inhaled via Spira nebuliser |
Contacts
Investigators
Principal Investigator
Carin Jorup
AstraZeneca R&D, Molndal
Sweden
