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


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

This study is currently recruiting patients.

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

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).

Condition	Treatment or Intervention	Phase
Diabetes Mellitus, Insulin-Dependent	Drug: hokt3g1 (ALA-ALA)	Phase I

MedlinePlus related topics: Juvenile Diabetes

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Official Title: Evaluation of tolerability, safety, and pharmacokinetics of hOKT3g1 (Ala-Ala)

Further Study Details:

Expected Total Enrollment: 12

Study start: June 2003; Study completion: June 2005

Eligibility

Ages Eligible for Study: 8 Years - 30 Years, Genders Eligible for Study: Both

Accepts Healthy Volunteers

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.

Location and Contact Information

New York
Columbia University, New York, New York, 10032, United States; Recruiting

Kevan Herold, MD 212-851-5492 kh318@columbia.edu

More Information

Study ID Numbers: ITNO17AI
Record last reviewed: June 2004
Record first received: November 18, 2003
ClinicalTrials.gov Identifier: NCT00073255
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

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