Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Process E Belatacept · 1 trial · 1 indication
(AUC\[INF\]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng\*h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)
Cmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in nanograms per milliliter.
| Arm | Type | Description |
|---|---|---|
| Process E Belatacept | OTHER | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E |
| Process C Belatacept | OTHER | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C |
| Name | Type | Description |
|---|---|---|
| Process E Belatacept | BIOLOGICAL | - |
| Process C Belatacept | BIOLOGICAL | - |
Inclusion Criteria: 1. Signed Informed Consent 2. Target population: Healthy males and females. 3. Males and females, ages 18 to 55 years, inclusive. 4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test 5. Women must not be breastfeeding 6. Men and WOCBP must agre...
Process E Belatacept is an investigational monoclonal antibody being studied for use in renal transplantation. It is a version of belatacept manufactured using a specific process, Process E, and is being evaluated in clinical trials to compare its pharmacokinetics with another manufacturing process.
Process E Belatacept is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this drug for renal transplantation.
Process E Belatacept is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under clinical investigation.
Process E Belatacept has one completed clinical trial, NCT02564497, which was a Phase 1 study comparing the pharmacokinetics of belatacept manufactured by Process E relative to Process C. The trial enrolled 491 participants and was conducted in the United States.
Process E Belatacept is a version of belatacept produced using a specific manufacturing process, Process E. It is being studied to compare its pharmacokinetic profile with belatacept made by Process C, indicating it is a formulation variant of the same drug.