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Botulism Antitoxin Bivalent Types A and B · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Stage A | EXPERIMENTAL | Botulism Antitoxin Bivalent (Equine) Types A and B Vs. Placebo |
| Stage B | EXPERIMENTAL | Botulism Antitoxin Heptavalent (Equine) Types A-G Vs. Placebo |
| Name | Type | Description |
|---|---|---|
| Botulism Antitoxin Bivalent (Equine) Types A and B | BIOLOGICAL | One vial of Botulism Antitoxin Bivalent(Equine) Types A and B (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage A |
| Botulism Antitoxin Heptavalent (Equine) Types A-G | BIOLOGICAL | One vial of Heptavalent Botulism Antitoxin (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage B |
Inclusion Criteria: * Male or female * Age 18 - 55 years * Body-mass index 19-30 * Normal and healthy as determined by medical history, physical examination, ECG, NCS, vital signs and tests of liver, kidney and hematological functions * Adequate form of contraception for female subjects * For wo...
Botulism Antitoxin Bivalent Types A and B is an investigational monoclonal antibody therapy developed by Emergent BioSolutions Inc. (EBS). It is being studied in healthy adult volunteers for its effects on paralysis induced by botulinum neurotoxins. The product is also known as Botulism Antitoxin Bivalent (Equine) Types A and B.
Botulism Antitoxin Bivalent Types A and B is developed by Emergent BioSolutions Inc., which trades on the New York Stock Exchange under the ticker EBS. The company is the sponsor of the clinical program evaluating this monoclonal antibody candidate.
Botulism Antitoxin Bivalent Types A and B 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, with no active trials currently listed.
Botulism Antitoxin Bivalent Types A and B has been studied in one completed Phase 1 trial, NCT00636519, titled Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle. The randomized, double-blind, controlled trial enrolled 36 healthy adult volunteers in the United States.