100
Participants
Start Date
December 31, 2023
Primary Completion Date
December 31, 2023
Study Completion Date
December 31, 2025
Collection of samples
To the extent possible, blood samples will be collected from all subjects prior to infusion and at specified time points post-infusion to determine serum obiltoxaximab concentrations and ATA titers. Scavenged blood samples can be utilized, if acceptable, to maximize sample analyses for pharmacokinetic and other investigational parameters. Data on other relevant laboratory testing will only be collected and evaluated if available in the subject's record (eg, protective antigen (PA), anti-PA, anti-lethal factor (LF), anti-edema factor, IgG antibodies, anthrax lethal toxin neutralizing activity, presence of anthrax LF, incidence and duration of B. anthracis bacteremia, and demonstration of B. anthracis antigens in tissues).
Obiltoxaximab
Obiltoxaximab standard of care
Lead Sponsor
Collaborators (1)
Centers for Disease Control and Prevention
FED
APCER Life Sciences
UNKNOWN
Elusys Therapeutics
OTHER