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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01203124
First received: September 15, 2010
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: AZD8848
Drug: Placebo
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo given once daily on 7 days
Drug: Placebo
Placebo
Experimental: 2
Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6
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.
Drug: Placebo
Placebo
Experimental: 3
Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6.
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.
Drug: Placebo
Placebo
Experimental: 4
Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6.
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.
Drug: Placebo
Placebo
Experimental: 5
Active treatment once daily on 7 days
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203124

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Leif T Eriksson, MD, PhD AstraZeneca
Principal Investigator: Wolfgang Kuhn, MD Quintiles
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01203124     History of Changes
Other Study ID Numbers: D0540C00016, 2010-022574-14
Study First Received: September 15, 2010
Last Updated: May 9, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Intranasal
Biomarker
Healthy
Effect of different doses and dosing regimens of AZD8848 on biomarkers
Effect different doses and dosing frequency of AZD8848 on biomarkers

ClinicalTrials.gov processed this record on April 17, 2014