23
Participants
Start Date
August 31, 2016
Primary Completion Date
October 31, 2016
Study Completion Date
October 31, 2016
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.
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.
Duke Early Phase Clinical Research (DEPRU), Durham
Foundation for the National Institutes of Health
OTHER
Robert J Noveck, M.D.
OTHER