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Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers

NCT01369017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-07-15

No results posted yet for this study

Summary

The investigators want to see if healthy people who are given 2 doses of a medication called anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then exposed to a form of air pollution, called Endotoxin, have less inflammation with the medication. Endotoxin is believed to be one of the causes of asthma attacks.

Conditions

  • Healthy Control Subjects

Interventions

DRUG

Anakinra

Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.

DRUG

Placebo

Injection of NS

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Michelle Hernandez, MD

    lead OTHER

Principal Investigators

  • Michelle Hernandez, MD · UNC CH SOM

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369017 on ClinicalTrials.gov