Inflammation and the Host Response to Injury (In Healthy Volunteers) (Mono)
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ClinicalTrials.gov Identifier: NCT00820989 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : May 21, 2014
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Condition or disease | Intervention/treatment | Phase |
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Immune System | Biological: Endotoxin, Lipopolysaccharide, LPS | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Inflammation and the Host Response to Injury (In Healthy Volunteers) |
Study Start Date : | February 2000 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: A
Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration).
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Biological: Endotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
Other Name: Sodium Chloride Solution |
- Physiological, Hematological, Immunological Responses [ Time Frame: .5-24 hours after Endotoxin administration ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820989
United States, New Jersey | |
Rutgers-RWJMS | |
New Brunswick, New Jersey, United States, 08850 |
Principal Investigator: | Siobhan Corbett, MD | Rutgers-RWJMS |
Responsible Party: | Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT00820989 |
Other Study ID Numbers: |
0220013432 GM64351-01 |
First Posted: | January 12, 2009 Key Record Dates |
Last Update Posted: | May 21, 2014 |
Last Verified: | May 2014 |
Healthy Immune System |
Inflammation Pathologic Processes |