Clinical trials: Botulism
Healthy
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).
- Trial name
- NCT04171115
- Testing
- G03-52-01
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Botulism
Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.
- Trial name
- rBV A/B (NCT01940315)
- Testing
- rBV A/B
- Volunteers
- healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Botulism
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism.
- Trial name
- NCT02051062
- Testing
- Blood sample collection
- Volunteers
- 10 people
- Sponsor
- Emergent BioSolutions
Healthy Volunteers
Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle
The primary purpose of this study is: 1. To evaluate the model determined by the ability of botulism antitoxin (bivalent, Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage…
- Trial name
- NCT00636519
- Testing
- Botulism Antitoxin Bivalent (Equine) Types A and B, Botulism Antitoxin Heptavalent (Equine) Types A-G
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
Botulism Vaccine
Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B
This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.
- Trial name
- NCT00764634
- Testing
- rBV A/B-40 vaccine
- Where
- 6 sites in United States
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company