| February 27, 2008 |
| October 8, 2008 |
| April 2001 |
| September 2001 (final data collection date for primary outcome measure) |
| To evaluate the safety and tolerability. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] |
| To evaluate the safety and tolerability of BSYX-A110 at doses of 3, 10 and 20 mg/kg in adults. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] |
| Complete list of historical versions of study NCT00636285 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants |
| 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 |
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. |
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. |
| Phase I |
| Interventional |
| Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study |
| Staphylococcal Sepsis |
- Drug: Placebo
- Drug: BSYX-A110
|
- Placebo Comparator: Placebo
- Experimental: BSYX-A110, Dosed intravenously, 3mg/kg
- Experimental: BSYX-A110, Dosed intravenously, 10mg/kg
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| |
| |
| Completed |
| 8 |
| November 2001 |
| September 2001 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 Criteria:
- 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.
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00636285 |
| Gerald Fischer, MD, President and CEO, Biosynexus Incorporated |
| MAB-A001 |
| Biosynexus Incorporated |
|
| Principal Investigator: |
Leonard Weisman, MD |
Baylor College of Medicine |
|
|
| Biosynexus Incorporated |
| October 2008 |