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

This study has been completed.
Sponsor:
Information provided by:
Biosynexus Incorporated
ClinicalTrials.gov Identifier:
NCT00636285
First received: February 27, 2008
Last updated: October 8, 2008
Last verified: October 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Placebo Comparator: 1
Placebo
Drug: Placebo
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

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:

  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.
  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:
No publications provided

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

Keywords provided by Biosynexus Incorporated:
A110
Safety

Additional relevant MeSH terms:
Birth Weight
Sepsis
Staphylococcal Infections
Bacteremia
Body Weight
Signs and Symptoms
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 14, 2014