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CompletedNCT00860821Updated Oct 28, 2009

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

An interventional study of AZD8309 and AZD8309 in Healthy, sponsored by AstraZeneca. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-28.

Sponsored by AstraZeneca · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Healthy

Keywords

  • Healthy subjects
  • LPS
  • Effect
  • Intranasally
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Clinical relevant disease and/or abnormality
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    1

    AZD8309

    Drug: AZD8309

  • Placebo comparator
    2

    Placebo

    Drug: AZD8309

Interventions

  • DrugAZD8309

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

  • DrugAZD8309

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

06

What researchers measure

Primary outcomes

  1. Neutrophil numbers in nasal lavage

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

Secondary outcomes

  1. Cells and inflammatory biomarkers in nasal lavage

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

  2. Cells and inflammatory biomarkers in blood

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

07

Study locations

1 site
  • Research Site
    Malmö, Sweden
08

References and documents

Publications

  • Leaker BR, Barnes PJ, O'Connor B. Inhibition of LPS-induced airway neutrophilic inflammation in healthy volunteers with an oral CXCR2 antagonist. Respir Res. 2013 Dec 16;14(1):137. doi: 10.1186/1465-9921-14-137. PubMed 24341382 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00860821
Lead sponsor
AstraZeneca
First posted
Mar 12, 2009
Start date
Mar 2009
Completion
Oct 2009
Last update
Oct 28, 2009

Study contacts

Lars Olaf Cardell
principal investigator · Department of Otorhinolaryngology, Malmö University Hospital, Sweden
Leif Eriksson
study director · AstraZeneca R&D Lund, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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