Study identifier:D1882C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD9164 given once daily as Inhaled Formulation via Turbuhaler for 13 days in Healthy Male and Female Subjects and in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Healthy, COPD
Phase 1
Yes
AZD9164 Turbuhaler®, Placebo Turbuhaler®
All
36
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Experimental: A AZD9164 | Drug: AZD9164 Turbuhaler® Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits. The COPD patients will receive a dose of 1000 µg. |
Placebo Comparator: B Placebo | Drug: Placebo Turbuhaler® Dry powder for inhalation via Turbuhaler, MAD |