NCT00513214

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

A Phase 1/2a, Double-blind, Placebo-controlled Study of the Safety and Pharmacokinetics of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: XOMA (US) LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Type 2 Diabetes

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-06-01
• Completion: 2010-02-01
• First posted: 2007-08-08
• Last updated: 2011-10-04

Locations

4 sites across 1 country: United States