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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: Completed Phase 1 study, sponsored by XBiotech.
NCT02357966 is a Phase 1 study that has completed, run by XBiotech. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose limiting Toxicity are defined as any Grade 3 or greater AE which is probably or definitely related to 514G3 occurring during the FU period after dosing. This measure determines and assesses the maximum tolerated dose (MTD) through participants who experienced DLT at different dose levels.
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 |
What the finished NCT02357966 record still lists
NCT02357966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02357966's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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