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Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00073255•National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

View on ClinicalTrials.gov

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).

Eligibility

Age

8 - 30 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion 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.

Locations (1)

Columbia University

New York, New York, United States

Key Dates

Start Date

June 1, 2003

Completion Date

December 1, 2005

Last Updated

January 15, 2010

Enrollment

Estimated participants

Conditions

Diabetes Mellitus, Insulin-Dependent

Interventions

hokt3g1 (ALA-ALA)

DRUG

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT07011147

Type 1 Diabetes (T1D)Type 2 Diabetes+9 more

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COMPLETEDNA

Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)

NCT00357890

Diabetes Mellitus, Insulin-Dependent

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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