Overview
Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
Status:
Completed
Completed
Trial end date:
2005-12-01
2005-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.