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

AstraZeneca20 enrolled

Overview

The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and inflammatory biomarkers in nasal lavage and blood after nasal challenge with lipopolysaccharide (LPS)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD8309DRUG

oral solution 30 mg/g, dose: 300mg bid for 3 days

AZD8309DRUG

oral solution 30 mg/g, dose: 300mg bid for 3 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men or healthy, permanently sterilized, women aged 18 to 50 years inclusive, non-smokers or ex-smokers, Body Mass Index 18 to 30 kg/m2 and minimum body weight of 50 kg * Blood neutrophil count above 2.2x10\^9/L Exclusion Criteria: * Clinical relevant disease and/or abnormality

Locations (1)

Research Site

Malmo, Sweden

Outcomes

Primary Outcomes

Neutrophil numbers in nasal lavage

Time frame: 3 times each in the end of two treatment periods

Secondary Outcomes

Cells and inflammatory biomarkers in nasal lavage

Time frame: 3 times in the end of the two treatment periods

Cells and inflammatory biomarkers in blood

Time frame: 2 times in the beginning and 5 times in the end of the two treatment periods

Data from ClinicalTrials.gov

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