CompletedPhase 1

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

Sweden55 participantsStarted 2010-11

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

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.

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.

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.

Trial details

NCT IDNCT01203124

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-03

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