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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 being studied in healthy volunteers. It is designed to counteract paralysis induced by botulinum neurotoxins types A and B. The drug is currently in Phase 1 clinical development and is not yet approved for any indication.
Botulism Antitoxin Bivalent Types A and B is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational antitoxin.
Botulism Antitoxin Bivalent Types A and B is in Phase 1 clinical development. A Phase 1 trial has been completed, involving 36 healthy volunteers in the United States. The drug remains investigational and has not received FDA approval.
Botulism Antitoxin Bivalent Types A and B has one completed clinical trial registered under NCT00636519, titled 'Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle.' This Phase 1 study enrolled 36 healthy volunteers in the United States and was a randomized, double-blind, controlled trial.
Botulism Antitoxin Bivalent Types A and B is a monoclonal antibody that targets botulinum neurotoxins types A and B. By binding to these toxins, the antitoxin is intended to neutralize their effects and prevent the paralysis they cause. The drug is being studied in healthy volunteers to assess its activity.