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A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma — MEDI-546  

Scleroderma Clinical Trial

Official title:
A Phase 1 Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor, in Adult Subjects With Scleroderma

Clinical Trial Summary

To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.

Clinical Trial Description

The primary objective of this study is to evaluate the safety and tolerability of single and multiple IV doses of MEDI-546 in adult subjects with scleroderma who have skin thickening in an area suitable for repeat biopsy. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00930683
Study type Interventional
Source MedImmune LLC
Contact
Status Completed
Phase Phase 1
Start date September 2009
Completion date July 2011
View Details
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