A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203124
• Other study ID #: D0540C00016
• Secondary ID: 2010-022574-14
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2010
• Last updated: August 13, 2015
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD8848
The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo.
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage		Samples collected pre-dose and 1 day after first dose.	No
Primary	CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage		Samples collected pre-dose and 7 days after first dose.	No
Primary	CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage		Samples collected pre-dose and 8 days after first dose.	No
Primary	CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage		Samples collected pre-dose and 10 days after first dose.	No
Primary	CXCL 10 (IP-10) and mRNA expression of IFNa regulated genes in blood and nasal lavage		Samples collected pre-dose and 12-14 days after first dose.	No
Secondary	To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens		During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose	No

External Links

•   CSR Synopsis