An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 31, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2025

Conditions
Infection, BacterialAnthrax
Interventions
OTHER

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).

BIOLOGICAL

Obiltoxaximab

Obiltoxaximab standard of care

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Centers for Disease Control and Prevention

FED

collaborator

APCER Life Sciences

UNKNOWN

lead

Elusys Therapeutics

OTHER

NCT03088111 - An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis | Biotech Hunter | Biotech Hunter