Clinical trial NCT01203124: A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Intranasal
Biomarker
Healthy
Effect of different doses and dosing regimens of AZD8848 on biomarkers
Effect different doses and dosing frequency of AZD8848 on biomarkers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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

Primary outcomes:
measure: CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
timeFrame: Samples collected pre-dose and 1 day after first dose.
measure: CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
timeFrame: Samples collected pre-dose and 7 days after first dose.
measure: CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
timeFrame: Samples collected pre-dose and 8 days after first dose.
measure: CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
timeFrame: Samples collected pre-dose and 10 days after first dose.
measure: CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
timeFrame: Samples collected pre-dose and 12-14 days after first dose.
Secondary outcomes:
measure: To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens
timeFrame: During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Leif T Eriksson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Wolfgang Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References: