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Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)

NCT00299819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2007-12-18

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.

Conditions

Interventions

BIOLOGICAL

MEDI-545

0.3 mg/kg IV (n=6) at Study Day 0

BIOLOGICAL

MEDI 545

0.3 mg/kg IV (n=6) at Study Day 0

BIOLOGICAL

MEDI-545

0.3 mg/kg IV (n=6) at Study Day 0

BIOLOGICAL

MEDI-545

0.3 mg/kg IV (n=6) at Study Day 0

BIOLOGICAL

MEDI-545

0.3 mg/kg IV (n=6) at Study Day 0

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Barbara White, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Completion
2007-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00299819 on ClinicalTrials.gov