Status:
COMPLETED
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
Lead Sponsor:
Biosynexus Incorporated
Conditions:
Staphylococcal Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2001
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00636285
Start Date
April 1 2001
End Date
November 1 2001
Last Update
October 9 2008
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030