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

XOMA

Status and phase

Completed

Phase 2

Conditions

Congenital Hyperinsulinism

Treatments

Drug: Cohort 4

Drug: Cohort 1

Drug: Cohort 3

Drug: Cohort 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02604485

X358602

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.