This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study
of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be
hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the
24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum
monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in
which they will receive a single intravenous infusion of active drug or placebo. Placebo will
be normal saline. Volunteers will be followed for safety for up to 120 days after infusion
depending on dose cohort.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)