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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02772718 | An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery | PHASE2 | COMPLETED | 20 | — | — | Apr 1, 2016 | May 1, 2021 | May 21, 2021 | 5 | United States |
Safety assessed by treatment-emergent adverse events
Glucose measured using a continuous glucose monitor
Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
Glucose measured by continuous glucose monitoring every 5 min
| Arm | Type | Description |
|---|---|---|
| Part 1 - single dose | EXPERIMENTAL | Cohorts A, B, and C |
| Part 2 - multiple doses | EXPERIMENTAL | Cohort 1 |
| Name | Type | Description |
|---|---|---|
| XOMA 358 single dose level A | DRUG | XOMA 358 single dose level A administered by intravenous infusion |
| XOMA 358 single dose level B | DRUG | XOMA 358 single dose level B administered by an intravenous infusion |
| XOMA 358 single dose level C | DRUG | XOMA 358 single dose level C administered by an intravenous infusion |
| XOMA 358 multiple dose level 1 | DRUG | XOMA 358 multiple dose level 1 administered by an intravenous infusion |
Inclusion Criteria: * Aged at least 18 years of age * Body Mass Index \< 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug. * Rec...