NCT01369017

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

A Study of the Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Center Reference Endotoxin in Normal Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Michelle Hernandez, MD · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-06-08
• Last updated: 2013-07-15

Locations

1 site across 1 country: United States