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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 14, 2014