Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)

Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)

To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).

To be eligible

• participants will have Type 1 diabetes, diagnosed within the previous 12 months and established by standard American Diabetes Association criteria.
• All participants will have autoantibodies: either anti-GAD65, anti-ICA512, or if treated with insulin for less than 7 days, anti-insulin.
• The age range will be between 8 and 30 years; and
• a minimum weight of 34 kg.