Skip to content

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

A Randomised, Double-blind, Placebo-controlled, Two-way Crossover, Single-centre Methodologhy Study in Healthy Subjects to Evaluate the Effect of Oral Dosing With AZD8309 on Cells and Inflammatory Biomarkers in Nasal Lavage and Blood After Nasal Challenge With Lipopolysaccharide (LPS).

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00860821
Enrollment
20
Registered
2009-03-12
Start date
2009-03-31
Completion date
2009-10-31
Last updated
2009-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects, LPS, Effect, Intranasally

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)

Interventions

DRUGAZD8309

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

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Neutrophil numbers in nasal lavage3 times each in the end of two treatment periods

Secondary

MeasureTime frame
Cells and inflammatory biomarkers in nasal lavage3 times in the end of the two treatment periods
Cells and inflammatory biomarkers in blood2 times in the beginning and 5 times in the end of the two treatment periods

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026