Completed

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

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What is being tested

Data Collection

Who is being recruted

Autoimmune Diseases+4

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 8 to 30 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2003

Actual date on which the first participant was enrolled.

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).

Official TitleEvaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala) 
NCT00073255
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesGlucose Metabolism Disorders

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Columbia University

New York, United StatesSee the location
CompletedOne Study Center