Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
Data Collection
Autoimmune Diseases+4
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Treatment Study
Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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