Clinical trials: Bacterial Enteritis
Healthy Volunteer
Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A
The purpose of this study is to determine the safe and optimal dose and regimen (fasting duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.
- Trial name
- NCT02773446
- Testing
- ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Bacterial Enteritis
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
- Trial name
- NCT02440633
- Testing
- 14C-OPS-2071
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bacterial Enteritis
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
- Trial name
- NCT02473393
- Testing
- OPS-2071 tablet
- Where
- 3 sites in Japan, Singapore and 1 more
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health