Dose-Related Inflammatory Effects of Intravenous Endotoxin in Humans

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Healthy
Interventions
BIOLOGICAL

Endotoxin

Reference Endotoxin is a purified LPS prepared from Escherichia coli O:113 (US Standard Reference Endotoxin); Clinical Center Reference Endotoxin (CCRE) Lot #94332B1 manufactured and vialed under GMP guidelines by List Biological Labs, Inc., 540 Division St., Campbell, CA 95008, for the Pharmacy Development Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA. The material has been approved by the FDA (Food and Drug Administration) for 'Investigational Use Only'. This specific Lot from List Biological Labs specified for use in this study contains 1 mcg/vial.

OTHER

Placebo

Normal saline will be administered as the control to evaluate the effects on the biomarkers over time and to compare the responses following LPS to those following the control injection of normal saline.

Trial Locations (1)

27710

Duke Early Phase Clinical Research (DEPRU), Durham

All Listed Sponsors
collaborator

Foundation for the National Institutes of Health

OTHER

lead

Robert J Noveck, M.D.

OTHER

NCT02789241 - Dose-Related Inflammatory Effects of Intravenous Endotoxin in Humans | Biotech Hunter | Biotech Hunter