Inflammation and the Host Response to Injury (In Healthy Volunteers)

NCT00820989 | Completed Phase 1

• 2 other identifiers: 0220013432GM64351-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

Conditions

Immune System

Keywords

Healthy Immune System

Outcome Measures

Primary Outcomes (1)

• Physiological, Hematological, Immunological Responses

  .5-24 hours after Endotoxin administration

Study Arms (1)

A

EXPERIMENTAL

Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration).

Biological: Endotoxin, Lipopolysaccharide, LPS

Interventions

Endotoxin, Lipopolysaccharide, LPS BIOLOGICAL

Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\~5 minutes)

Also known as: Sodium Chloride Solution

A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.
• Written informed consent prior to the performance of any study related procedure.

You may not qualify if:

• History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
• Recent history of alcohol or drug abuse
• Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures
• Exposure to any experimental agent or procedure within 30 days of study
• Pregnancy or breast feeding
• Prior exposure to endotoxin in an experimental setting -

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers-RWJMS

New Brunswick, New Jersey, 08850, United States

Location

MeSH Terms

Interventions

Endotoxins; Lipopolysaccharides; Sodium Chloride

Intervention Hierarchy (Ancestors)

Bacterial Toxins; Toxins, Biological; Biological Factors; Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Siobhan Corbett, MD

  Rutgers-RWJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: February 1, 2000
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)