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

Phase 1CompletedNCT01203124

AstraZeneca55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteers

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.

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Uppsala, Sweden