NCT00930683

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Scleroderma

Interventions

Type	Name	Description
DRUG	MEDI-546	0.1 mg/kg MEDI-546 as a single IV dose
DRUG	MEDI-546	0.3 mg/kg MEDI-546 as a single IV dose
DRUG	MEDI-546	1.0 mg/kg MEDI-546 as a single IV dose
DRUG	MEDI-546	3.0 mg/kg MEDI-546 as a single IV dose
DRUG	MEDI-546	10.0 mg/kg MEDI-546 as a single IV dose
DRUG	MEDI-546	0.3 mg/kg MEDI-546 as a weekly IV dose x 4 doses
DRUG	MEDI-546	1.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses
DRUG	MEDI-546	5.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses
DRUG	MEDI-546	20.0 mg/kg MEDI-546 as a single IV dose

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-05-01
• Completion: 2011-07-01
• First posted: 2009-06-30
• Last updated: 2012-05-08

Locations

11 sites across 1 country: United States