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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: AZD8848

• Registration Number: NCT01203124
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2010-11
• Primary Completion: 2011-03
• Study Completion: 2012-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo given once daily on 7 days
2	Placebo	Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6
5	AZD8848	Active treatment once daily on 7 days
4	AZD8848	Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6.
2	AZD8848	Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6
3	Placebo	Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6.
3	AZD8848	Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6.
4	Placebo	Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6.

Primary Outcome Measures

Name	Time	Method
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage	Samples collected pre-dose and 12-14 days after first dose.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden