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)...
Date First Received: November 18, 2003
Last Updated: December 6, 2007
Verified by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2007
Clinical Trial Phase: Phase 1 | Start Date: June 2003
Overall Status: Completed
Estimated Enrollment: 12
Brief Summary
Official Title: “Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: hokt3g1 (ALA-ALA)
Criteria for Participation in this Clinical Trial
- 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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 8 Years
Maximum Age for this Clinical Trial: 30 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional Information
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00073255
Study ID Number: ITNO17AI
ClinicalTrials.gov Identifier: NCT00073255
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
