100
Participants
Start Date
May 31, 2026
Primary Completion Date
May 31, 2035
Study Completion Date
December 31, 2035
Sample Collection
"Whenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations.~Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels."
Lead Sponsor
Centers for Disease Control and Prevention
FED
Biomedical Advanced Research and Development Authority
FED
Emergent BioSolutions
INDUSTRY