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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Staphylococcus Aureus Bacteremia
Interventions
BIOLOGICAL

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

True Human Monoclonal Antibody

BIOLOGICAL

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

True Human Monoclonal Antibody

BIOLOGICAL

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

True Human Monoclonal Antibody

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

Trial Locations (2)

28203

XBiotech Investigative Site, Charlotte

31904

XBiotech Investigative Site, Columbus

All Listed Sponsors
lead

XBiotech, Inc.

INDUSTRY

NCT02357966 - Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects. | Biotech Hunter | Biotech Hunter