Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Insulin-Dependent
Intervention: hokt3g1 (ALA-ALA) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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).
Clinical Details
Official title: Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Eligibility
Minimum age: 8 Years.
Maximum age: 30 Years.
Gender(s): Both.
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.
Locations and Contacts
Columbia University, New York, New York 10032, United States
Additional Information
Starting date: June 2003
Ending date: December 2005
Last updated: December 6, 2007
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