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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)12 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Insulin-Dependent

Interventions

hokt3g1 (ALA-ALA)DRUG

Eligibility

Sex: ALLMin age: 8 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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