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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: AZD8848

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203124

2010-022574-14 (EudraCT Number)

D0540C00016

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo given once daily on 7 days

Treatment:

Drug: Placebo

2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: AZD8848

3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: AZD8848

4

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: AZD8848

5

Experimental group

Description:

Active treatment once daily on 7 days

Treatment:

Drug: AZD8848