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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.
 
ClinicalTrials.gov Identifier: NCT00636285
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : October 9, 2008
Sponsor:
Information provided by:
Biosynexus Incorporated

Tracking Information
First Submitted Date  ICMJE February 27, 2008
First Posted Date  ICMJE March 14, 2008
Last Update Posted Date October 9, 2008
Study Start Date  ICMJE April 2001
Actual Primary Completion Date September 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2008)
To evaluate the safety and tolerability. [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2008)
To evaluate the safety and tolerability of BSYX-A110 at doses of 3, 10 and 20 mg/kg in adults. [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT00636285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcal Sepsis
Intervention  ICMJE
  • Drug: Placebo
    Placebo
    Other Names:
    • Pagibaximab
    • BSYX-A110
  • Drug: BSYX-A110
    BSYX-A110, Dosed intravenously, 3 mg/kg
    Other Name: Pagibaximab
  • Drug: BSYX-A110
    BSYX-A110, Dosed intravenously, 10 mg/kg
    Other Name: Pagibaximab
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    BSYX-A110, Dosed intravenously, 3mg/kg
    Intervention: Drug: BSYX-A110
  • Experimental: 3
    BSYX-A110, Dosed intravenously, 10mg/kg
    Intervention: Drug: BSYX-A110
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2008)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2001
Actual Primary Completion Date September 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636285
Other Study ID Numbers  ICMJE MAB-A001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerald Fischer, MD, President and CEO, Biosynexus Incorporated
Study Sponsor  ICMJE Biosynexus Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonard Weisman, MD Baylor College of Medicine
PRS Account Biosynexus Incorporated
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP