Ebola Treatment in Early-Stage Trial.

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A first-in-human trial evaluating an experimental treatment for Ebola virus disease has begun at the National Institutes of Health Clinical Center, Bethesda, Md. The Phase 1 clinical trial is examining the safety and tolerability of a single monoclonal antibody called mAb114, which was developed by scientists at the National Institute of Allergy and Infectious Diseases, part of NIH, and their collaborators. Investigators aim to enroll healthy volunteers aged 18 to 60. Participants will not be exposed to Ebola virus.

Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain, and hemorrhage (severe bleeding). It was first discovered in humans in 1976 in the Democratic Republic of the Congo (DRC) and has caused periodic cases and outbreaks in several African countries since then. The largest outbreak, which occurred in West Africa from 2014-16, caused over 28,600 infections and more than 11,300 deaths, according to the World Health Organization.

In May, the DRC reported an Ebola out-break, located in Equateur Province in the northwest of the country. Health officials have reported 51 probable or confirmed cases and 27 deaths. There currently are no licensed treatments available, although multiple experimental therapies are being developed.

"We hope this trial will establish the safety of this experimental treatment for Ebola virus disease--an important first step in a larger evaluation process," says NIAID Director Anthony S. Fauci. "Ebola is highly lethal, and reports of another outbreak in the DRC remind us that we urgently need Ebola treatments."

MAb114 is a monoclonal antibody--a protein that binds to a single target on a pathogen--isolated from a human...

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