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NCT02357966 · ClinicalTrials.gov registry record · Phase 1
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
A Phase 1 study, sponsored by XBiotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02357966 is a Phase 1 study that has completed, run by XBiotech. The registered enrollment target is 52 participants.
The verdict
NCT02357966, a Phase 1 study, has completed, sponsored by XBiotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study 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.
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
- BIOLOGICAL 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02357966
The ClinicalTrials.gov registry entry for NCT02357966 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XBiotech, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 514G3 (2 mg/kg) plus standard IV antibiotic treatment is the first listed.
NCT02357966 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02357966 about?
NCT02357966 is a clinical study titled "Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.". 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 51...
What is the current status of trial NCT02357966?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2015-05. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02357966?
The interventions under investigation include: 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 (BIOLOGICAL), Placebo plus standard IV antibiotic treatment (OTHER), 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II (BIOLOGICAL).
Who is sponsoring clinical trial NCT02357966?
This trial is sponsored by XBiotech, which has 4 total clinical trials registered on ClinicalTrials.gov.
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