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A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

NCT01127321 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-08-26

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

Conditions

  • Lupus Erythematosus, Systemic

Interventions

OTHER

Placebo

A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.

BIOLOGICAL

MEDI-570 0.03 MG

A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.

BIOLOGICAL

MEDI-570 0.1 MG

A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.

BIOLOGICAL

MEDI-570 0.3 MG

A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.

BIOLOGICAL

MEDI-570 1 MG

A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • David Close, PhD · MedImmune Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Canada
  • Mexico
  • Peru
  • South Africa

Study Locations

More Related Trials

Entities

Companies

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 NCT01127321 on ClinicalTrials.gov