Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses

Phase 1 Completed 40 enrolled Emergent BioSolutions Department of Health and Human Services · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2006-07
Primary completion: 2006-12
Completion: 2010-04

Publications

Background Middlebrook JL. Protection strategies against botulinum toxin. Adv Exp Med Biol. 1995;383:93-8. doi: 10.1007/978-1-4615-1891-4_11. No abstract available.
Background Gelzleichter TR, Myers MA, Menton RG, Niemuth NA, Matthews MC, Langford MJ. Protection against botulinum toxins provided by passive immunization with botulinum human immune globulin: evaluation using an inhalation model. J Appl Toxicol. 1999 Dec;19 Suppl 1:S35-8. doi: 10.1002/(sici)1099-1263(199912)19:1+3.0.co;2-9.
Background Hibbs RG, Weber JT, Corwin A, Allos BM, Abd el Rehim MS, Sharkawy SE, Sarn JE, McKee KT Jr. Experience with the use of an investigational F(ab')2 heptavalent botulism immune globulin of equine origin during an outbreak of type E botulism in Egypt. Clin Infect Dis. 1996 Aug;23(2):337-40. doi: 10.1093/clinids/23.2.337.
Background Metzger JF, Lewis GE Jr. Human-derived immune globulins for the treatment of botulism. Rev Infect Dis. 1979 Jul-Aug;1(4):689-92. doi: 10.1093/clinids/1.4.689.
Background Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. doi: 10.1128/CMR.13.4.602.
Background Cupo P, de Azevedo-Marques MM, Sarti W, Hering SE. Proposal of abolition of the skin sensitivity test before equine rabies immune globulin application. Rev Inst Med Trop Sao Paulo. 2001 Jan-Feb;43(1):51-3. doi: 10.1590/s0036-46652001000100010.
Background Chippaux JP, Lang J, Eddine SA, Fagot P, Rage V, Peyrieux JC, Le Mener V. Clinical safety of a polyvalent F(ab')2 equine antivenom in 223 African snake envenomations: a field trial in Cameroon. VAO (Venin Afrique de l'Ouest) Investigators. Trans R Soc Trop Med Hyg. 1998 Nov-Dec;92(6):657-62. doi: 10.1016/s0035-9203(98)90802-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NP-018	Protein / enzyme biologic	1 unknown	Intravenous
Subject	NP-018	Protein / enzyme biologic	2 unknown	Intravenous

Indications

No indication recorded.