Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03040687 | Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge | PHASE1 | COMPLETED | 60 | — | — | Jan 1, 2017 | Aug 1, 2017 | Jun 14, 2019 | 1 | United States |
Number of Participants with adverse events in groups receiving B7A- and CS6- hyperimmune (BSIgG) compared with the group receiving the nonhyperimmune product.
Comparison of the number and percentage of volunteers in the arms receiving the B7A- and CS6 BSIgG vs the arm receiving the nonhyperimmune BSIgG who develop moderate to severe diarrhea.
| Arm | Type | Description |
|---|---|---|
| Anti-CS6 group | EXPERIMENTAL | Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A) |
| Anti-whole cell B7A | EXPERIMENTAL | Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A) |
| control Immunoglobulin group | EXPERIMENTAL | Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A) |
| Name | Type | Description |
|---|---|---|
| Anti CS6 BSIgG product (Lot PD1601105CS) | BIOLOGICAL | - |
| Anti B7A BSIgG product (Lot PD1601132ET) | BIOLOGICAL | - |
| Bovine Immunoglobin Negative Control (Lot PD161071NC) | BIOLOGICAL | - |
| B7A- CS6-expressing ETEC challenge strain | BIOLOGICAL | - |
Inclusion Criteria: * Male or female between 18 and 50 years of age, inclusive. * General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator (PI) or PI in consultation with the researc...