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

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

This study has been completed.

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)
ClinicalTrials.gov Identifier:	NCT00073255

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

MedlinePlus related topics:

Diabetes Diabetes Type 1

U.S. FDA Resources

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 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

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073255

Locations


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

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Study ID Numbers:	ITNO17AI
First Received:	November 18, 2003
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00073255
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus, Type 1

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 07, 2008