Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
NCT ID: NCT02357966
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2015-05-31
2016-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose of the study drug (514G3). Eligible subjects will be randomized (3:1) to receive single dose of 514G3 (Either 2, 10, 40 mg/kg) plus standard IV antibiotic therapy or single dose of placebo plus standard IV antibiotic therapy.
A phase 2 of the trial is designed to assess the preliminary efficacy through randomization of subjects in two arm groups i.e. a single dose of 514G3 administered at the RP2D with standard IV treatment or placebo plus standard IV treatment.
Eligible subjects will be randomized (2:1) to receive either a single dose of 514G3 plus standard IV antibiotic therapy versus a single dose of placebo plus standard IV antibiotic treatment.
TREATMENT
DOUBLE
Study Groups
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Phase I
A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose (RP2D) of the study drug (514G3).
Randomized subjects were administered the study drug at 3 dose levels i.e. 2 mg/kg, 10 mg/kg, and 40 mg/kg or placebo.
514G3 (2 mg/kg) plus standard IV antibiotic treatment
True Human Monoclonal Antibody
514G3 (10 mg/kg) plus standard IV antibiotic treatment
True Human Monoclonal Antibody
514G3 (40 mg/kg) plus standard IV antibiotic treatment
True Human Monoclonal Antibody
Placebo plus standard IV antibiotic treatment
Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment
Phase II
A phase 2 of the trial is a dose expansion study designed to assess the preliminary efficacy. Eligible subjects are randomized (2:1) and received a single dose of 40 mg/kg study drug (514G3) with standard IV treatment versus placebo with standard IV treatment.
514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II
A single dose of 514G3 plus standard IV antibiotic therapy
Placebo plus standard IV antibiotic treatment: Phase II
A single dose of placebo plus standard IV antibiotic therapy
Interventions
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514G3 (2 mg/kg) plus standard IV antibiotic treatment
True Human Monoclonal Antibody
514G3 (10 mg/kg) plus standard IV antibiotic treatment
True Human Monoclonal Antibody
514G3 (40 mg/kg) plus standard IV antibiotic treatment
True Human Monoclonal Antibody
Placebo plus standard IV antibiotic treatment
Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment
514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II
A single dose of 514G3 plus standard IV antibiotic therapy
Placebo plus standard IV antibiotic treatment: Phase II
A single dose of placebo plus standard IV antibiotic therapy
Eligibility Criteria
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Inclusion Criteria
2. Temperature ≥ 38.0°C
3. Age ≥18, male or female subjects.
4. Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of normal (ULN).
5. Adequate hepatic function
6. Adequate bone marrow function
7. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
8. Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed.
9. Expected survival of at least 2 months.
Exclusion Criteria
2. Known or suspected osteomyelitis or meningitis.
3. Patients that are being mechanically ventilated as a result of a pulmonary infection at the time of screening. Mechanical ventilation for other reasons, such as trauma, is acceptable.
4. Presence of any removable infection source (e.g., intravascular line, abscess, or prosthesis) that will not be removed or debrided within 3 days after randomization.
5. Definite or possible left-sided endocarditis, by Modified Duke Criteria, based on screening echocardiogram. Subjects with suspected right-sided endocarditis are permitted.
6. Need for emergent valve surgery at the time of screening, and/or the presence of decompensated heart failure or cardiogenic shock.
7. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
8. Infection with human immunodeficiency virus (HIV) and a CD4 count \<200 cells/mm3.
9. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to 514G3 or any component of its formulations.
10. Women who are pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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XBiotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Rupp, M.D.
Role: STUDY_CHAIR
University of Nebraska
Locations
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XBiotech Investigative Site
Columbus, Georgia, United States
XBiotech Investigative Site
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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2014-PT029
Identifier Type: -
Identifier Source: org_study_id
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