The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
London, United Kingdom
Incidence of treatment-emergent adverse events
Safety assessed by treatment-emergent adverse events
Time frame: 42 days
Change from baseline in glucose levels as measured using a continuous glucose monitor
Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results
Time frame: 42 days
Fasting and post prandial blood glucose levels
Assessment of blood glucose collected at time points specified in the protocol
Time frame: 42 days
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XOMA 358 single dose level D administered by an intravenous infusion