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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02604485

Enrollment

Registered

2015-11-13

Start date

2015-10-31

Completion date

2017-01-31

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hyperinsulinism

Keywords

Hypoglycemia, Congenital Hyperinsulinism

Brief 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.

Interventions

DRUGCohort 1

XOMA 358 single dose level A administered by an intravenous infusion

DRUGCohort 2

XOMA 358 single dose level B administered by an intravenous infusion

DRUGCohort 3

XOMA 358 single dose level C administered by an intravenous infusion

DRUGCohort 4

XOMA 358 single dose level D administered by an intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events	42 days	Safety assessed by treatment-emergent adverse events
Change from baseline in glucose levels as measured using a continuous glucose monitor	42 days	Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results
Fasting and post prandial blood glucose levels	42 days	Assessment of blood glucose collected at time points specified in the protocol

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026