Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): An open-label phase 1 study
The Lancet Jan 30, 2019
Gaudinski MR, et al. - In this phase 1, dose-escalation study (VRC 608), researchers assessed mAb114 (a single monoclonal antibody targeting the receptor-binding domain of Ebola virus glycoprotein) for safety, tolerability, pharmacokinetics, and immunogenicity in treating the Ebola virus. This investigation was conducted at the US National Institutes of Health (NIH) Clinical Center (Bethesda, MD). For this analysis, healthy adults (aged 18–60 years) were sequentially enrolled into three mAb114 dose groups of 5 mg/kg, 25 mg/kg, and 50 mg/kg. The drug was intravenously given to participants for more than 30 minutes and participants were followed for 24 weeks. According to findings, mAb114 was well tolerated, exhibited linear pharmacokinetics and was infused quickly and easily, making it an attractive and deployable treatment option in outbreak settings. No unsolicited adverse events associated with mAb114 occurred.
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