National Institutes of Health (NIH) early-stage clinical trial findings maintain the investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer.
Trial results published in The Lancet outlined the manner in which 18 healthy adults received mAb114 as part of a May 2018 Phase 1 clinical trial at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, with the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) developed the investigational treatment and conducted and sponsored the clinical trial.
Officials said Phase 1 clinical trial participants received a single intravenous infusion of mAb114, administered over approximately 30 minutes. Three participants received a five milligram (mg) / kilogram (kg) dose; five participants received a 25 mg/kg dose, and 10 participants received a 50 mg/kg dose. All infusions were well-tolerated.
NIH officials said there are several advantages for deploying mAb114 in an outbreak setting, including ease and speed of its administration and its formulation as a freeze-dried powder that does not require freezer storage. The powder is reconstituted with sterile water and added to saline for administration.
VRC scientists developed mAb114 in collaboration with colleagues at the National Institute of Biomedical Research (INRB) in the Democratic Republic of the Congo, the Institute for Research in Biomedicine and Vir Biotechnology Inc.’s subsidiary Humabs BioMed, and the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md.