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Tracking Information | |||||
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First Received Date ICMJE | February 27, 2008 | ||||
Last Updated Date | October 8, 2008 | ||||
Start Date ICMJE | April 2001 | ||||
Primary Completion Date | September 2001 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To evaluate the safety and tolerability. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
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 ] | ||||
Change History | Complete list of historical versions of study NCT00636285 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE | Staphylococcal Sepsis | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 8 | ||||
Completion Date | November 2001 | ||||
Primary Completion Date | September 2001 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00636285 | ||||
Other Study ID Numbers ICMJE | MAB-A001 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Gerald Fischer, MD, President and CEO, Biosynexus Incorporated | ||||
Study Sponsor ICMJE | Biosynexus Incorporated | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Biosynexus Incorporated | ||||
Verification Date | October 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |