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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

AZD8848 Single Ascending Dose Study

NCT01560234

Healthy

COMPLETED PHASE1

To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses AZD8848 in Healthy Subjects

NCT01818869

Safety, Tolerability, Healthy Subjects

COMPLETED PHASE1

A Methodology Study in Healthy Subjects to Evaluate the Effect of AZD8309 After Nasal Administration of Lipopolysaccharide (LPS)

NCT00860821

Healthy

COMPLETED NA

Study to Investigate the Effect of a Single Dose of AZD7624 on Inflammation Caused by an Endotoxin Challenge

NCT01937338

LPS Challenge, Neutrophils

COMPLETED PHASE1

Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

NCT00940212

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Placebo given once daily on 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

2

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

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo

3

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

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo

4

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

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo

5

Active treatment once daily on 7 days

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes