To assess the safety, tolerability, and pharmacokinetics of AZD7624 in healthy volunteers and COPD patients
Study identifier:D2550C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients with COPD
Medical condition
COPD, Healthy subjects
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD7624, Placebo to match
Sex
All
Actual Enrollment
52
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Sept 2013
Primary Completion Date: 01 Oct 2014
Study Completion Date: 01 Oct 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Feb 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo. | Drug: AZD7624 Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer |
| Placebo Comparator: 2 Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo. | Drug: Placebo to match Multiple doses inhaled placebo via a nebulizer |
Contacts
Investigators
Principal Investigator
Saeed Khan
Quintiles Drg Research Centre At Guys Hosipital, 6 Newcomen Street London SE1 1YR
