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

NCT02604485 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-02-06

No results posted yet for this study

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.

Conditions

  • Congenital Hyperinsulinism

Interventions

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

Sponsors & Collaborators

  • XOMA (US) LLC

    lead INDUSTRY

Principal Investigators

  • Allan Gordon, MD, PhD · XOMA (US) LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604485 on ClinicalTrials.gov