Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants - Full Text View

Sponsor:	Biosynexus Incorporated
Information provided by:	Biosynexus Incorporated
ClinicalTrials.gov Identifier:	NCT00636285

Purpose

The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers. Following the demonstration of safety in adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized low birth weight neonates.

Condition	Intervention	Phase
Staphylococcal Sepsis	Drug: Placebo Drug: BSYX-A110	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetics Study in Adults of BSYX-A110, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Pagibaximab

U.S. FDA Resources

Further study details as provided by Biosynexus Incorporated:

Primary Outcome Measures:

To evaluate the safety and tolerability. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the serum levels (pharmacokinetics) of anti-LTA antibodies (ELISA; the functional opsonic activity against S. epidermidis; and correlate the levels of anti-LTA antibodies achieved with opsonic activity against S. epidermidis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment:	8
Study Start Date:	April 2001
Study Completion Date:	November 2001
Primary Completion Date:	September 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo Placebo
2: Experimental BSYX-A110, Dosed intravenously, 3mg/kg	Drug: BSYX-A110 BSYX-A110, Dosed intravenously, 3 mg/kg
3: Experimental BSYX-A110, Dosed intravenously, 10mg/kg	Drug: BSYX-A110 BSYX-A110, Dosed intravenously, 10 mg/kg

Detailed Description:

This study will evaluate the safety of three doses of BSYX-A110 in adults before initiating studies in the target population of low birth weight infants. This will be an open label, dose-ranging study of BSYX-A110 in 12 adults. The dose levels to be evaluated are 3, 10 and 20 mg/kg. Each dose level will enroll 4 adult volunteers who will receive one dose of BSYX-A110 intravenously. The primary endpoint of this study is safety and tolerability. The secondary endpoints include the pharmacokinetics of the rise in anti-LTA antibody and opsonic activity against S. epidermidis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must be 18 years of age or older.
Subjects must in good general health, without significant medical history, physical examination findings or clinical laboratory abnormalities.
Negative screening pre-treatment pregnancy test for female subjects.
Subjects of childbearing potential must agree to use an acceptable method of contraception throughout the course of the study.
All aspects of the protocol explained and written informed consent obtained.

Exclusion Criteria:

Known or suspected immunodeficiency (e.g. HIV infection, significant risk factors for HIV, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression.
Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
History of leukemia, lymphoma or other malignancy.
Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
Receipt of any vaccine within 30 days.
History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study.
Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
Participation in another investigational drug or vaccine trial within 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636285

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Biosynexus Incorporated

Investigators

Principal Investigator:

Leonard Weisman, MD

Baylor College of Medicine

More Information

Additional Information:

Biosynexus Incorporated This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Biosynexus Incorporated ( Gerald Fischer, MD, President and CEO )
Study ID Numbers:	MAB-A001
Study First Received:	February 27, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00636285 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosynexus Incorporated:

A110
Safety

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Body Weight
Birth Weight
Signs and Symptoms
Staphylococcal Infections

Sepsis
Gram-Positive Bacterial Infections
Pathologic Processes
Bacteremia
Infection
Inflammation

ClinicalTrials.gov processed this record on November 30, 2009