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)

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 Overview

• Status: Completed
• Conditions: Congenital Hyperinsulinism
• Intervention / Treatment: Drug: Cohort 1; Drug: Cohort 2; Drug: Cohort 3; Drug: Cohort 4

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort; XOMA 358 dose level A, dose level B, dose level C, and dose level D.	Drug: Cohort 1; XOMA 358 single dose level A administered by an intravenous infusion; Drug: Cohort 2; XOMA 358 single dose level B administered by an intravenous infusion; Drug: Cohort 3; XOMA 358 single dose level C administered by an intravenous infusion; Drug: Cohort 4; XOMA 358 single dose level D administered by an intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events	Safety assessed by treatment-emergent adverse events	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	42 days
Fasting and post prandial blood glucose levels	Assessment of blood glucose collected at time points specified in the protocol	42 days

Collaborators and Investigators

• Sponsor: XOMA (US) LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Hypoglycemia; Congenital Hyperinsulinism
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Hypoglycemia; Hyperinsulinism; Congenital Hyperinsulinism; Nesidioblastosis
• Other Study ID Numbers: X358602