Multiple ascending doses (MAD) of AZD3199 given once daily as inhaled formulation via Turbuhaler to healthy men - AZD3199MAD
Study identifier:D0570C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A phase I, randomised, double-blind, placebo-controlled, parallel-group, single-centre study to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of AZD3199 (a B2-agonist) given once daily as inhaled formulation via Turbuhaler to healthy men
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3199, Placebo
Sex
Male
Actual Enrollment
27
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Nov 2008
Study Completion Date: 01 Nov 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Low dose | Drug: AZD3199 Low dose Dry powder for inhalation, o.d., 1+12 days |
| Experimental: 2 intermediate dose | Drug: AZD3199 intermediate dose Dry powder for inhalation, o.d., 1+12 days |
| Experimental: 3 high dose | Drug: AZD3199 high dose Dry powder for inhalation, o.d., 1+12 days |
| Placebo Comparator: 4 | - |
Contacts
Investigators
Principal Investigator
Gabriella Samuelsson Palmgren
AZ CPU Lund, Sweden
