NCT01203124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

4 months

First QC Date

September 15, 2010

Last Update Submit

August 13, 2015

Conditions

Healthy Volunteers

Keywords

IntranasalBiomarkerHealthyEffect of different doses and dosing regimens of AZD8848 on biomarkersEffect different doses and dosing frequency of AZD8848 on biomarkers

Outcome Measures

Primary Outcomes (5)

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

    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

    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

    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

    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

    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

    During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose

Study Arms (5)

1

PLACEBO COMPARATOR

Placebo given once daily on 7 days

Drug: Placebo

2

EXPERIMENTAL

Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6

Drug: AZD8848Drug: Placebo

3

EXPERIMENTAL

Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6.

Drug: AZD8848Drug: Placebo

4

EXPERIMENTAL

Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6.

Drug: AZD8848Drug: Placebo

5

EXPERIMENTAL

Active treatment once daily on 7 days

Drug: AZD8848

Interventions

AZD8848DRUG

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.

2345
PlaceboDRUG

Placebo

1234

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

Related Links

MeSH Terms

Interventions

AZD8848

Study Officials

  • Leif T Eriksson, MD, PhD

    AstraZeneca

    STUDY DIRECTOR

  • Wolfgang Kuhn, MD

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

February 1, 2012

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

SE(1)