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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636285
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : October 9, 2008
Information provided by:
Biosynexus Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Staphylococcal Sepsis Drug: Placebo Drug: BSYX-A110 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2001
Actual Primary Completion Date : September 2001
Actual Study Completion Date : November 2001

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
Drug: Placebo
Other Names:
  • Pagibaximab
  • BSYX-A110

Experimental: 2
BSYX-A110, Dosed intravenously, 3mg/kg
Drug: BSYX-A110
BSYX-A110, Dosed intravenously, 3 mg/kg
Other Name: Pagibaximab

Experimental: 3
BSYX-A110, Dosed intravenously, 10mg/kg
Drug: BSYX-A110
BSYX-A110, Dosed intravenously, 10 mg/kg
Other Name: Pagibaximab

Primary Outcome Measures :
  1. To evaluate the safety and tolerability. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
  3. Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
  4. History of leukemia, lymphoma or other malignancy.
  5. Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
  6. Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
  7. Receipt of any vaccine within 30 days.
  8. 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.
  9. Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
  10. Participation in another investigational drug or vaccine trial within 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00636285

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biosynexus Incorporated
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Principal Investigator: Leonard Weisman, MD Baylor College of Medicine

Additional Information:
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Responsible Party: Gerald Fischer, MD, President and CEO, Biosynexus Incorporated Identifier: NCT00636285    
Other Study ID Numbers: MAB-A001
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: October 9, 2008
Last Verified: October 2008
Keywords provided by Biosynexus Incorporated:
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs