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

This study has been completed.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: November 18, 2003
Last updated: January 14, 2010
Last verified: January 2010

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 Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Drug: hokt3g1 (ALA-ALA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)

Resource links provided by NLM:

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 12
Study Start Date: June 2003
Estimated Study Completion Date: December 2005

Ages Eligible for Study:   8 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00073255

United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
  More Information

No publications provided Identifier: NCT00073255     History of Changes
Other Study ID Numbers: ITNO17AI (completed)
Study First Received: November 18, 2003
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases processed this record on November 20, 2014