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

NCT00930683 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-05-08

No results posted yet for this study

Summary

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

Conditions

  • Scleroderma

Interventions

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Stephen Yoo, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-05-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930683 on ClinicalTrials.gov