Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anti CS6 BSIgG product · 1 trial · 1 indication
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...
Anti CS6 BSIgG product is an investigational monoclonal antibody being studied in healthy volunteers. It is being evaluated for its efficacy against E. coli strain B7A challenge, as part of a Phase 1 clinical trial. The product is not approved and remains in clinical development.
Anti CS6 BSIgG product is being developed by United Therapeutics Corporation, which trades under the ticker UTHR. The company is conducting a Phase 1 clinical trial to evaluate the product's efficacy in healthy volunteers.
Anti CS6 BSIgG product is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with 60 participants enrolled.
Anti CS6 BSIgG product is associated with one completed clinical trial, NCT03040687, titled 'Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge.' This Phase 1 study enrolled 60 healthy volunteers in the United States and was randomized, double-blind, and controlled.
Anti CS6 BSIgG product is related to B7A BSIgG, as the clinical trial NCT03040687 evaluates the efficacy of B7A BSIgG against E. coli strain B7A challenge. The product is an investigational monoclonal antibody being developed by United Therapeutics Corporation.