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NCT00073255 Clinical Trial

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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official title:
Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073255
Other study ID # ITNO17AI (completed)
Secondary ID
Status Completed
Phase Phase 1
First received November 18, 2003
Last updated January 14, 2010
Start date June 2003
Est. completion date December 2005

Study information
Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 30 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• hokt3g1 (ALA-ALA)

Locations
Country Name City State
United States Columbia University New York New York

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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