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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
BSYX-A110, Dosed intravenously, 3mg/kg
干预措施: BSYX-A110 (Drug)
3
BSYX-A110, Dosed intravenously, 10mg/kg
干预措施: BSYX-A110 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability.
时间窗: 28 days
次要结局
- 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)