The US National Institutes of Health’s (NIH) Clinical Center in Bethesda, Maryland, US, has started the VRC 608 Phase l clinical trial to evaluate the safety and tolerability of mAb114 for the treatment of Ebola virus disease.
The first-in-human, open-label, dose-escalation trial aims to enrol 18 to 30 healthy subjects aged 18 to 60.
As part of the trial, the first three participants will receive a 5mg/kg intravenous infusion of mAb114 for 30 minutes.
The trial’s monitoring team will analyse safety data to determine if the remaining participants can receive higher doses, including 25mg/kg and 50mg/kg of mAb114.
Investigators will take blood from the subjects before and after the infusion and will ask them to record their temperature and any symptoms for three days at home.
The subjects will visit the clinic around 14 times over six months to have their blood drawn to test if mAb114 is detectable and to be checked for any health changes.
NIH unit National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) Clinical Trials Program medical director Martin Gaudinski is the principal investigator of the VRC 608 trial, which expects to complete enrolment by July this year.
NIAID director Anthony Fauci said: “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.
“Ebola is highly lethal, and reports of another outbreak in the Democratic Republic of the Congo (DRC) remind us that we urgently need Ebola treatments.”
MAb114 is a monoclonal antibody and was developed by scientists at NIAID and their collaborators.
The experimental treatment has previously demonstrated its ability to bind itself to the hard-to-reach core of the Ebola virus surface protein and blocks the protein’s interaction with its receptor on human cells.