Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360737
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2006-07-19
Brief Title:
Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
Sponsor:
Emergent BioSolutions
Organization:
Emergent BioSolutions
Study Overview
Official Title:
Pharmacokinetics of a Heptavalent Equine-derived Botulinum Antitoxin NP-018
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Fab2 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
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 Fab2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None