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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: AZD8309

• Registration Number: NCT00860821
• Lead Sponsor: AstraZeneca

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-27
• Last Update Posted: 2009-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD8309	AZD8309
2	AZD8309	Placebo

Primary Outcome Measures

Name	Time	Method
Neutrophil numbers in nasal lavage	3 times each in the end of two treatment periods

Secondary Outcome Measures

Name	Time	Method
Cells and inflammatory biomarkers in nasal lavage	3 times in the end of the two treatment periods
Cells and inflammatory biomarkers in blood	2 times in the beginning and 5 times in the end of the two treatment periods

Trial Locations

Locations (1)

Research Site; 🇸🇪 Malmö, Sweden