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Also known as Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)
Botulinum Antitoxin Heptavalent · 1 trial · 1 indication
Number of subjects with AEs and severity of AEs up to Day 28
Number of subjects with SAEs up to Day 28
| Arm | Type | Description |
|---|---|---|
| NP-018 - 1 vial | EXPERIMENTAL | Subjects received one vials of NP-018 administered intravenously. |
| NP-018 - 2 vials | EXPERIMENTAL | Subjects receive two vials of NP-018 administered intravenously. |
| Name | Type | Description |
|---|---|---|
| Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) | BIOLOGICAL | Biological/Vaccine NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from pooled plasma obtained from horses that have been immunized against one of seven botulinum antitoxins (A-G). . |
Inclusion Criteria: * Body-mass index of 20 to 30 with minimum body weight of 111 lb (50 kg). * For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including: * Using hormonal contraception (oral or injectable or impla...
Botulinum Antitoxin Heptavalent is an investigational equine-derived antitoxin designed to neutralize seven botulinum neurotoxin serotypes, labeled A, B, C, D, E, F, and G. It is being developed by Emergent BioSolutions Inc. (ticker EBS) as a countermeasure against botulism poisoning caused by these serotypes.
Botulinum Antitoxin Heptavalent targets SNAP25, a hydrolytic enzyme component of the synaptic vesicle fusion machinery. Botulinum neurotoxins cleave SNAP25 to block neurotransmitter release, and the antitoxin is intended to bind and neutralize the seven toxin serotypes before they can act on this target.
Emergent BioSolutions Inc., which trades under the ticker EBS, is the developer of Botulinum Antitoxin Heptavalent. The product is derived from horses, as reflected in its full name, Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE).
Botulinum Antitoxin Heptavalent is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has one completed Phase 1 trial, and no trials are currently active.
Botulinum Antitoxin Heptavalent has been studied in one completed Phase 1 trial, NCT00360737, titled Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses. The trial enrolled 40 healthy adult volunteers in the United States, was randomized, double-blind, and controlled, and included both sexes.
Yes. Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) is the full name of the same product, and the shorter form Botulinum Antitoxin Heptavalent refers to it as well. The parenthetical letters denote the seven botulinum neurotoxin serotypes A, B, C, D, E, F, and G that the antitoxin covers.