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

Phase 2

Completed

• Conditions: Congenital Hyperinsulinism
• Interventions: Drug: Cohort 1; Drug: Cohort 2; Drug: Cohort 3; Drug: Cohort 4

• Registration Number: NCT02604485
• Lead Sponsor: XOMA (US) LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Cohort 2	XOMA 358 dose level A, dose level B, dose level C, and dose level D.
Cohort	Cohort 3	XOMA 358 dose level A, dose level B, dose level C, and dose level D.
Cohort	Cohort 4	XOMA 358 dose level A, dose level B, dose level C, and dose level D.
Cohort	Cohort 1	XOMA 358 dose level A, dose level B, dose level C, and dose level D.

Primary Outcome Measures

Name	Time	Method
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