Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin
      Serotypes derived from horses using various laboratory measurements, clinical examinations
      and adverse events. In addition, following intravenous (injected into the vein)
      administration assessing how much 7 Botulinum Antitoxin remains in the body.
    

Detailed description: 
      Clostridial toxins are amongst the most toxic substances known to science (Middlebrook,
      1995). In the United States and other countries, human exposure to Clostridium botulinum
      toxins usually occurs through food poisoning, wound botulism and colonizing infections in
      neonates. Recent events have heightened concern about the possibility of botulinum toxins
      being used in a bioterrorist attack. In order to be prepared for a biological attack as well
      as the usual human exposures, numerous therapeutic products have been or currently are
      undergoing development to treat or prevent botulism, including the use of human or equine
      derived antibodies for post-exposure prophylaxis of botulinum toxin exposure (Gelzleichter et
      al, 1999; Hibbs et al, 1996; Metzger and Lewis, 1979 and Keller and Stiehm, 2000).

      Botulinum antitoxins have been in use to treat adult exposure to botulinum toxin for at least
      40 years (Cupo et al, 2001). The use of botulinum antitoxins to treat individuals exposed to
      botulinum toxin is similar to the use of passive immune therapy with immune globulins
      collected from immunized or convalescing human donors to treat a wide range of bacterial and
      viral infectious diseases (Chippaux et al, 1998).

      NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from plasma obtained from
      horses that have been immunized with a specific subtype of botulinum toxoid and toxin. Each
      individual horse is immunized against a single botulinum toxin subtype. Plasma is pooled from
      horses that have been immunized with the same botulinum toxin subtype. For each antitoxin
      serotype (A-G), a despeciated product will be produced by pepsin digestion of the IgG monomer
      in the equine plasma, yielding predominantly F(ab¢)2 fragment. Following the formulation, the
      seven antitoxin serotypes will be blended into a heptavalent product and filled into
      single-use vials.

      The present clinical study is intended to assess the pharmacokinetics and safety of NP 018
      following intravenous administration. The pharmacokinetics of NP 018 will be comparable to
      other equine derived antitoxin products. NP 018 will be safe to administer to normal healthy
      volunteers.
    

Intervention name(s): Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)
Intervention type(s): Biological
Intervention description(s): Biological/Vaccine NP-018 Experimental with 8 Cohorts of 5 Subjects each evaluating 2 Dosage levels of 1 or 2 vials of NP-018 administered intravenously.
Other intervention name(s): Botulism Antitoxin (BAT)
Intervention MeSH terms: Antitoxins; Botulinum Antitoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Clinical Trials; Investigational Drug; Healthy Volunteers; Botulinum Antitoxin; Phoenix, Arizona