TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

Inclusion Criteria:

• Adults 12 to 45 years old who are in good general health
• Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
• Measurable C-peptide levels

Exclusion Criteria:

• Females must not be pregnant or lactating and willing to practice contraception
• No prior malignancy, other than non-melanoma skin cancer
• Body Mass Index (BMI) > 32 at screening