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Dose-Related Inflammatory Effects of Intravenous Endotoxin in Humans

NCT02789241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-04-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate 4-dose levels of CCRE Lot 94332B1 (0.6, 1.0, 2.0, and 4.0 ng/kg). This study is known as, an "endotoxin challenge." Thousands of healthy subjects worldwide over the last 20 years have participated in endotoxin challenge studies as part of clinical research and clinical drug development programs. This study will only test the safety and tolerability of CCRE Lot 94332B1.

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.

Sponsors & Collaborators

Principal Investigators

  • Robert J Noveck, MD, PhD · Medical Director, Duke Early Phase Clinical Research (DEPRU)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789241 on ClinicalTrials.gov