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Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.

NCT02357966 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-09

Study results available
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Summary

This study is a Phase I/II, double-blind, placebo-controlled trial investigating the True Human monoclonal antibody 514G3 in subjects hospitalized with Staphylococcus aureus bacteremia. Phase I involves dose escalation to evaluate potential toxicity and establish the recommended phase 2 dosage of 514G3. In Phase II (dose expansion), eligible subjects will be randomized at a ratio of 2:1 to receive either a single dose of 514G3 with standard IV antibiotic therapy or a single dose of placebo with standard IV antibiotic therapy, aiming to assess safety and tolerability. The trial aims to determine the safety, efficacy, and optimal dosage regimen of 514G3 in these hospitalized subjects.

Conditions

  • Staphylococcus Aureus Bacteremia

Interventions

BIOLOGICAL

514G3 (2 mg/kg) plus standard IV antibiotic treatment

BIOLOGICAL

514G3 (10 mg/kg) plus standard IV antibiotic treatment

BIOLOGICAL

514G3 (40 mg/kg) plus standard IV antibiotic treatment

OTHER

Placebo plus standard IV antibiotic treatment

Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment

BIOLOGICAL

514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II

A single dose of 514G3 plus standard IV antibiotic therapy

OTHER

Placebo plus standard IV antibiotic treatment: Phase II

A single dose of placebo plus standard IV antibiotic therapy

Sponsors & Collaborators

  • XBiotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Rupp, M.D. · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02357966 on ClinicalTrials.gov