The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in healthy male and female subjects and COPD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
36
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.
Dry powder for inhalation via Turbuhaler, MAD
Research Site
Linköping, Sweden
Research Site
Luleå, Sweden
Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Pharmacokinetics samples for AZD9164
Time frame: PK sampling during the residential period and intense PK sampling day 1 and 15 in healthy and day 13 in COPD patients
Investigation of PD effects
Time frame: Spirometry at screening and during the residential stay
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