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Completed

NCT Number: NCT01203124

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8848

Drug

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

Drug

Placebo

Primary outcomes

  1. CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage

    Time frame: Samples collected pre-dose and 1 day after first dose.

  2. CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage

    Time frame: Samples collected pre-dose and 7 days after first dose.

  3. CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage

    Time frame: Samples collected pre-dose and 8 days after first dose.

  4. CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage

    Time frame: Samples collected pre-dose and 10 days after first dose.

  5. CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage

    Time frame: Samples collected pre-dose and 12-14 days after first dose.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 16, 2010
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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