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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02564497 | A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C | PHASE1 | COMPLETED | 491 | — | — | Oct 2, 2015 | Jan 27, 2017 | Apr 17, 2019 | 1 | United States |
(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...