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Adrecizumab-LPS Study

NCT03083171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-01

No results posted yet for this study

Summary

In this randomized, double-blind, placebo-controlled study, either a single dose of Adrecizumab (0.5, 2.0 or 8.0 mg/kg) or placebo will be administrated to 24 healthy male volunteers during experimental endotoxemia.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Endotoxin

At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng/kg/hour for 3 hours.

DRUG

Placebo

At T=1 hour, placebo will be administered intravenously over a 1 hour period. Placebo is indistinguishable from Adrecizumab.

DRUG

Adrecizumab

At T=1 hour, Adrecizumab will be administered intravenously over a 1 hour period.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Adrenomed AG

    lead INDUSTRY

Principal Investigators

  • Peter Pickkers, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2017-05-24
Completion
2017-05-24

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 NCT03083171 on ClinicalTrials.gov