A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC

Criteria

Inclusion Criteria:

• Clinical diagnosis of congenital hyperinsulinism

• Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.

• Can safely washout of background medications used to treat hyperinsulinism.

Exclusion Criteria:

• Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism

• Body Mass Index ≥ 35 kg/m2

• Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding

• Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.