Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
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First Received Date ICMJE | July 19, 2006 | ||||
Last Updated Date | June 8, 2011 | ||||
Start Date ICMJE | July 2006 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Serum for Antitoxins and Pk analysis [ Time Frame: (Day 2 Screening, 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal) ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00360737 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses | ||||
Official Title ICMJE | Pharmacokinetics of a Heptavalent Equine-derived Botulinum Antitoxin (NP-018) | ||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE | Biological: Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)
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 Name: Botulism Antitoxin (BAT) |
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Study Arm (s) | Active Comparator: NP-018
Subjects received one or two vials of NP-018 administered intravenously.
Intervention: Biological: Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 40 | ||||
Completion Date | April 2010 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00360737 | ||||
Other Study ID Numbers ICMJE | AA24424 BT-001 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Fran Yadao, Manager Clinical Operations, Cangene Corp. | ||||
Study Sponsor ICMJE | Cangene Corporation | ||||
Collaborators ICMJE | Department of Health and Human Services | ||||
Investigators ICMJE |
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Information Provided By | Cangene Corporation | ||||
Verification Date | June 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |