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Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

NCT00513214 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2011-10-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in subjects with stable Type 2 Diabetes Mellitus (T2D).

The study is a dose-escalation study designed to evaluate route of administration (intravenous or subcutaneous), doses, and dosing regimens for future studies.

Conditions

Interventions

DRUG

XOMA 052

* Part 1, Single IV infusion at one of six dose levels (mg/kg). * Part 2, Single SC injection at one of three dose levels (mg/kg). * Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).

DRUG

Placebo

* Part 1, Single IV infusion at one of six dose levels (mg/kg). * Part 2, Single SC injection at one of three dose levels (mg/kg). * Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).

Sponsors & Collaborators

  • XOMA (US) LLC

    lead INDUSTRY

Principal Investigators

  • Pedro Urquilla, MD · XOMA (US) LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-06-30
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00513214 on ClinicalTrials.gov