NCT02357966

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: XBiotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Phase I/II trial aims to assess the safety and efficacy of True Human monoclonal antibody 514G3 in hospitalized subjects with Staphylococcus aureus bacteremia. Phase I entails dose escalation, with subjects randomized (3:1) at three dose levels of the study drug (2 mg/kg, 10 mg/kg, and 40 mg/kg) and placebo, utilizing central randomization. Dose-limiting toxicities (DLTs), defined as Grade 3 or greater adverse events related to 514G3 during follow-up, guide escalation. The Maximum Tolerated Dose (MTD) is determined based on DLT occurrence. Phase II, focusing on preliminary efficacy, randomizes eligible subjects (2:1) to receive 514G3 or placebo with standard IV antibiotic therapy. Safety and efficacy assessments are conducted for both phases, encompassing pooled data from both the study drug and placebo groups.

Conditions

• Staphylococcus Aureus Bacteremia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-02-06
• Last updated: 2026-02-09
• Results posted: 2024-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study