AZD9164 Single Ascending Dose Study in Healthy Male Subjects
NCT00847249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2009-09-23
Summary
The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.
Conditions
- Healthy
Interventions
- DRUG
-
AZD9164
Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
- DRUG
-
Each subject will receive a single-dose.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Anders Luts · AstraZeneca
-
Ulf Malmqvist · Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-02-28
- Completion
- 2009-04-30
Countries
- Sweden
Study Locations
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