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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Insulin-Dependent

• Registration Number: NCT00073255
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-11-18
• Study First Submitted QC: 2003-11-19
• Study First Posted: 2003-11-20
• Study Completion: 2005-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States