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

• Status: Completed
• Trial end date: 2001-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biosynexus Incorporated
• Treatments: Antibodies, Monoclonal

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.