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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01369017

Acronym

Kintox

Enrollment

Registered

2011-06-08

Start date

2011-10-31

Completion date

2013-07-31

Last updated

2013-07-15

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

Conditions

Healthy Control Subjects

Keywords

healthy volunteer, endotoxin

Brief 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.

Interventions

DRUGAnakinra

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

DRUGPlacebo

Injection of NS

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy volunteers * age 18-50 years

Exclusion criteria

* asthma * pregnant women * smokers

Design outcomes

Primary

Measure	Time frame	Description
blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE	6 hours after inhalation of CCRE	The primary endpoints for this study will be a) safety assessments of anakinra with CCRE inhalation and b) the post CCRE challenge percentage of neutrophils (%PMN) in airway sputum during the anakinra treatment period compared to the placebo treatment period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026