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

2014-08-27 03:54:45 | BioPortfolio

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).

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Insulin-Dependent

Intervention

hokt3g1 (ALA-ALA)

Location

Columbia University
New York
New York
United States
10032

Status

Completed

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:45-0400

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Medical and Biotech [MESH] Definitions

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A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).

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