The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
XOMA 358 single dose level A administered by intravenous infusion
XOMA 358 single dose level B administered by an intravenous infusion
XOMA 358 single dose level C administered by an intravenous infusion
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
Safety assessed by treatment-emergent adverse events
Time frame: 42 days
Single dose Part 1 - Change from baseline in glucose levels
Glucose measured using a continuous glucose monitor
Time frame: Baseline and 22 days
Single dose Part 1 - Blood glucose levels
Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
Time frame: Daily through Day 11 and at Day 22
Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol
Glucose measured by continuous glucose monitoring every 5 min
Time frame: 28 days
Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol
Time frame: 28 days
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XOMA 358 multiple dose level 1 administered by an intravenous infusion
Rochester, Minnesota, United States