Subcutaneous Administration of Otelixizumab to T1DM Patients

Summary

This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information which will enable the identification of appropriate safe and well-tolerated subcutaneous dosage regimens to be used in subsequent clinical studies. This study will consist of a screening phase, followed by an in-house phase whereby otelixizumab will be administered to cohorts that will be staggered at each dose level.

Timeline

Start

2009-07-08

Primary completion

2011-08-01

Completion

2013-06-25

Drugs

Indications