Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XOMA 358 single · 1 trial · 1 indication
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...
XOMA 358 single is being studied for the treatment of hypoglycemia, specifically low blood sugar occurring after gastric bypass surgery. It is an investigational small molecule developed in the metabolic therapeutic area. The clinical work to date has focused on patients 18 years and older with this post-surgical hypoglycemia condition.
XOMA 358 single is being developed by XOMA Royalty Corporation, which trades under the ticker XOMA. The company sponsored the clinical study of the drug in patients with hypoglycemia following gastric bypass surgery.
XOMA 358 single has been evaluated in a Phase 2 clinical study. It is an investigational agent and is not described as approved. The Phase 2 trial has been completed, and no trials of this drug are currently listed as active.
XOMA 358 single was studied in one completed Phase 2 trial, NCT02772718, titled an open-label study of XOMA 358 in patients with hypoglycemia after gastric bypass surgery. The trial enrolled 20 patients in the United States, included both sexes, and required participants to be at least 18 years old.
Yes, XOMA 358 single dose level A is another name used for XOMA 358 single. Both names refer to the same investigational small molecule studied in patients with hypoglycemia after gastric bypass surgery.
The Phase 2 trial of XOMA 358 single, NCT02772718, was not randomized and was not double blind. It used a controlled design and was conducted as an open-label study. The trial enrolled 20 patients and has been completed.