At a glance
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A Phase I-II Study of the Safety and Efficacy of a True Human Antibody, 514G3, in Subjects Hospitalized With Bacteremia Due to Staphylococcus Aureus
In Brief
A Phase 2 clinical trial evaluating 514G3 (2 mg/kg) plus standard IV antibiotic treatment, 514G3 (10 mg/kg) plus standard IV antibiotic treatment, and 4 other interventions for Staphylococcus Aureus Bacteremia. Completed, enrolled 52 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment
A single dose of 514G3 plus standard IV antibiotic therapy
A single dose of placebo plus standard IV antibiotic therapy