NCT00541983

Single-dose, Dose-escalation Study of Safety, PK, and Preliminary Efficacy of XOMA 052 in Type 2 Diabetes Mellitus

A Phase I, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• 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, pharmacokinetics (PK) and preliminary efficacy of XOMA 052 in subjects with active Type 2 Diabetes Mellitus (T2D). IV administration of XOMA 052 is likely to improve glycemic control in subjects with T2D by blocking certain receptors.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	XOMA 052	Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.
DRUG	Placebo	Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-07-01
• Completion: 2010-02-01
• First posted: 2007-10-10
• Last updated: 2010-05-04

Locations

2 sites across 1 country: Switzerland