Status:
COMPLETED
A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage.
Eligibility Criteria
Inclusion
- Healthy men or women aged 18 to 55 years (inclusive). Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method, with additional use of a condom by male partners, until 3 months after last dose.
- Female subjects should have a negative pregnancy test at Visit 2 and date of last menstruation consistent of non-pregnancy
- Ability to metabolise AZD8848 (an in vitro screening assay will determine metabolic activity in a blood sample taken at Visit 1 using a pre-defined limit)
Exclusion
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in physical examination
- Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction
- Ongoing pregnancy or lactation
- Abnormal immune function
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01203124
Start Date
November 1 2010
End Date
February 1 2012
Last Update
August 14 2015
Active Locations (1)
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1
Research Site
Uppsala, Sweden