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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203124

Enrollment

Registered

2010-09-16

Start date

2010-11-30

Completion date

2012-02-29

Last updated

2015-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Intranasal, Biomarker, Healthy, Effect of different doses and dosing regimens of AZD8848 on biomarkers, Effect different doses and dosing frequency of AZD8848 on biomarkers

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.

Interventions

DRUGAZD8848

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.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026