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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Hyperinsulinism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort

XOMA 358 dose level A, dose level B, dose level C, and dose level D.

Group Type OTHER

Cohort 1

Intervention Type DRUG

XOMA 358 single dose level A administered by an intravenous infusion

Cohort 2

Intervention Type DRUG

XOMA 358 single dose level B administered by an intravenous infusion

Cohort 3

Intervention Type DRUG

XOMA 358 single dose level C administered by an intravenous infusion

Cohort 4

Intervention Type DRUG

XOMA 358 single dose level D administered by an intravenous infusion

Interventions

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Cohort 1

XOMA 358 single dose level A administered by an intravenous infusion

Intervention Type DRUG

Cohort 2

XOMA 358 single dose level B administered by an intravenous infusion

Intervention Type DRUG

Cohort 3

XOMA 358 single dose level C administered by an intravenous infusion

Intervention Type DRUG

Cohort 4

XOMA 358 single dose level D administered by an intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No