Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110 (N002)
Phase I/II Randomized, Double Blind, Placebo Controlled, Dose Escalation, Safety and Pharmacokinetics Study in VLBW Neonates, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis Infection" will be the first study of BSYX-A110 in the target population of hospitalized, very low birth weight infants. The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
This will be a randomized, double blind, placebo controlled, dose escalating study of BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30, 60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth. Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The primary objective of this study is to evaluate safety and tolerability. The secondary objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during the study period will be recorded and analyzed.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must meet all of the following criteria at the time of first infusion (Day 0):
- 3-7 days of age, inclusive
- Birth weight of 700-1300 grams
- Survival expected for at least 1 week after infusion
- Inpatient in a Neonatal Intensive Care Unit with intravenous access
- Written informed consent obtained from the parent(s) or guardian
Multiple gestations:
- Siblings from multiple gestations may be enrolled if they each meet the entry criteria
- No more than 4 subjects in any birth weight or dose cohort may be siblings
Exclusion Criteria:
Patients may have none of the following at either the first or second dose:
- Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
- Life threatening hemodynamic instability
Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) as determined by history and/or physical examination and including but not limited to:
i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
- Known or suspected hepatic or renal insufficiency
- Persistent seizure disorder
- Immunodeficiency other than due to prematurity
- A history of immune globulin administration prior to first study drug infusion
- Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
Any of the following laboratory findings
- BUN or creatinine > 1.5 x upper limit of normal for age
- AST (SGOT), ALT (SGPT) or total bilirubin > 1.5 x upper limit of normal age
- Direct bilirubin of > 2.0 mg/dL
- Hemoglobin < 9.0gm/dL
- White Blood Count < 2,000 cells/mm3
- Currently receiving or recently received other investigational agents that could interfere with conduct or results of this study. Each patient receiving other investigational agents will be reviewed by the investigator or his designee with the Sponsor prior to the patient's entry into the study.
- Expectation that the patient will not be able to be followed for the duration of the study.
- Mother with serology positive for hepatitis B surface antigen
- Receipt of Hepatitis B vaccine since birth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
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Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other Names:
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Experimental: 10 mg/kg
10 mg/kg was given on Days 0, 14
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Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other Names:
|
|
Experimental: 30 mg/kg
30 mg/kg was given on Days 0, 14
|
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other Names:
|
|
Experimental: 60 mg/kg
60 mg/kg was given on Days 0, 14
|
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other Names:
|
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Experimental: 90 mg/kg
90 mg/kg was given on Days 0, 14
|
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and tolerability.
Time Frame: 0 - 52 days
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0 - 52 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the pharmacokinetics and positive cultures.
Time Frame: 0 - 52 days
|
0 - 52 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MAB-N002
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