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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biosynexus Incorporated
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and tolerability.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
1
Placebo
Intervention: Placebo (Drug)
2
BSYX-A110, Dosed intravenously, 3mg/kg
Intervention: BSYX-A110 (Drug)
3
BSYX-A110, Dosed intravenously, 10mg/kg
Intervention: BSYX-A110 (Drug)
Outcomes
Primary Outcomes
To evaluate the safety and tolerability.
Time Frame: 28 days
Secondary Outcomes
- 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(28 days)