Safety and Pharmacokinetics of a Single ZMappTM Administration in Healthy Adult Volunteers

Summary

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.

Timeline

Start

2015-03-11

Primary completion

2017-12-27

Completion

2017-12-27

Drugs

Indications

No indication recorded.