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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2015 |
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Main ID: |
NCT01203124 |
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Date of registration:
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15/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers
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Scientific title:
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A Single-blind, Randomized, Placebo Controlled, Parallel-group, Adaptive-design Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 Administered Intranasally for up to 7 Days, on the Biomarker |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01203124 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Leif T Eriksson, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Wolfgang Kuhn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Quintiles |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Placebo
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Drug: AZD8848
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Primary Outcome(s)
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CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage
[Time Frame: Samples collected pre-dose and 8 days after first dose.]
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CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage
[Time Frame: Samples collected pre-dose and 7 days after first dose.]
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CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage
[Time Frame: Samples collected pre-dose and 1 day after first dose.]
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CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage
[Time Frame: Samples collected pre-dose and 12-14 days after first dose.]
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CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage
[Time Frame: Samples collected pre-dose and 10 days after first dose.]
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Secondary Outcome(s)
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To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens
[Time Frame: During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose]
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Secondary ID(s)
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D0540C00016
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2010-022574-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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