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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Insulin-Dependent

Treatments: Drug: hokt3g1 (ALA-ALA)

Study type: Interventional

Funder types: NIH

Identifiers

NCT00073255

ITNO17AI (completed)

Details and patient eligibility

About

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).

Sex: All

Ages: 8 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)