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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, United States
Safety and tolerability of XOMA 3AB: occurrence of adverse events and serious adverse events.
Time frame: Day 0 to Day 90 and to Day 120 (depending on dose cohort).
Safety and tolerability of XOMA 3AB: Changes from baseline in vital signs, physical examinations, chemistry and complete blood count with differential laboratory studies, dipstick urinalysis, and electrocardiograms.
Time frame: Day 0, 1, 2, 3, 7, 14, 28, 42, 56, Day 90 and to 120 days (depending on dose cohort).
Immunogenicity: measuring Human anti-human antibodies (HAHA) to XOMA 3AB
Time frame: Day 0, 28, 56, 90 and 120 days (depending on dose cohort).
Pharmacokinetics of XOMA 3AB:Area under the curve to the last time with a measurable value (AUC(0-t))
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Volume of distribution (Vz)
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Total clearance (CL)
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Elimination half-life (t½)
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Elimination rate constant (gimel z)
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Area under the curve to infinity (AUC(inf))
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Time to Cmax (Tmax) measured from end of infusion
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Maximum plasma titer/concentration (Cmax)
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
Pharmacokinetics of XOMA 3AB: Mean residence time (MRT)
Time frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort)
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