A Phase 1a Open-Label Study to Assess the Safety and Pharmacokinetics of a Single ZMappTM Administration in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To evaluate the safety of a single IV infusion of 50 mg/kg of ZMappTM
研究概览
简要总结
Background:
- Ebola is a virus that can spread quickly and causes serious disease. It is currently causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a new drug made of natural infection-fighting substances. Researchers want to see if it can treat Ebola.
Objective:
- To assess the safety of ZMappTM and how the body processes it. To measure the immune system response to ZMappTM.
Eligibility:
- Healthy people 18 50 years old.
Design:
- Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have an electrocardiogram (ECG) to measure heart electrical activity. Small pads will be stuck to the arms, legs, and chest.
- Participants will be admitted to the hospital. They will have a physical exam, medication review, and blood samples.
- Two intravenous (IV) lines will be placed into separate arm veins. A needle will be used to guide plastic tubing into the veins. One will be used to take blood samples. The other will be used to give the study drug.
- Participants will be given drugs to help prevent side effects.
- Participants will be given the study drug by IV over 10 12 hours. Participants will be monitored closely and vital signs taken frequently. They may have another ECG.
- Blood samples will be taken before, during, and after the infusion.
- Participants will stay in the hospital 1 or 2 nights after receiving the drug.
- Participants will have several study visits over 90 days after getting the study drug. They will be asked about side effects. They may have a physical exam, and blood may be drawn.
详细描述
Ebola virus (EBOV) is associated with high morbidity and mortality rates in patients presenting clinical illness. Currently, no agent is approved in the U.S. or elsewhere for the therapeutic treatment of EBOV. The current standard of care for EBOV infection is limited to supportive treatment.
ZMapp TM, a combination of three chimeric human/murine monoclonal antibodies against the EBOV surface glycoprotein found on virions and infected cells, is being developed as a treatment for Ebola virus disease. This is a Phase 1a, open-label study to assess the safety and pharmacokinetics of a single intravenous administration of ZMapp tm in healthy adult volunteers. Three subjects will receive a single intravenous dose of 50mg/kg infusion and be evaluated on study Days 0, 1, 2, 7, 14, 21, 28, 60, and 90. Samples will be collected for pharmacokinetic and immunogenicity assessments at baseline, during, and following infusion. Subjects will be monitored and assessed for safety and the incidence of adverse events over the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OPEN
healthy volunteers between the ages of 18-50 to receive a one-time infusion of Zmapp at a dose of 50mg/kg.
干预措施: ZMAPP (Drug)
结局指标
主要结局
To evaluate the safety of a single IV infusion of 50 mg/kg of ZMappTM
时间窗: at 8 time points through 90 days following infusion
To determine serum pharmacokinetics following an intravenous (IV) infusion of 50 mg/kg of ZMappTM
时间窗: at 8 time points through 90 days following infusion
次要结局
- To assess the development of anti-drug antibodies (ADAs) elicited following a single IV infusion of 50 mg/kg of ZMappTM(at 8 time points through 90 days following infusion)