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PK/PD of EA-230 During Endotoxemia

NCT02629874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-06-23

No results posted yet for this study

Summary

EA-230 is a newly developed synthetic compound with anti-inflammatory properties. Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation resulting from a variety of causes such as surgery, trauma, infection, irradiation and others. Although previous studies in healthy volunteers have shown an excellent safety profile, the safety and tolerability of higher doses administered per continuous infusion need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be further elucidated before a phase II trial in patients can be commenced.

Conditions

  • Endotoxemia
  • Systemic Inflammatory Response

Interventions

DRUG

EA-230

at t=0 30, 90 or 180 mg/kg EA-230 will be administered intravenously over 2 hours.

DRUG

Endotoxin

at t=0 2ng/kg purified E.Coli endotoxin is administered intravenously

DRUG

Placebo

Sponsors & Collaborators

  • Exponential Biotherapies Inc.

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • P Pickkers, MD, Prof. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT02629874 on ClinicalTrials.gov