Clinical trials: Botulism
Botulism
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent…
- Trial name
- NCT06112834
- Testing
- rBV A/B
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- California Department of Public Health
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
Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632
This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
- Trial name
- NCT02779140
- Testing
- NTM-1632
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Botulism
Phase 1 PK Study of XOMA 3AB
This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers.
- Trial name
- NCT01357213
- Testing
- XOMA 3AB
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
- Trial name
- NCT03603665
- Testing
- NTM-1633
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Botulism
Study of the Drug B11-FC (Botulism Treatment)
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults
- Trial name
- NCT06580236
- Testing
- B11-FC, Botulinum neurotoxin type A
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Botulism
Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine A/B (rBV A/B) for the production of BabyBIG in…
- Trial name
- NCT01701999
- Testing
- rBV A/B
- Where
- 2 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- California Department of Public Health
Botulism
Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent…
- Trial name
- NCT03676634
- Testing
- rBV A/B
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- California Department of Public Health
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