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A Study of the Safety and Tolerability of MEDI-551 in Scleroderma

NCT00946699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-11-13

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-551 over escalating single doses in adult subjects with Scleroderma

Conditions

  • Scleroderma

Interventions

BIOLOGICAL

MEDI-551

0.1 mg/kg

BIOLOGICAL

Placebo

0.3 mg/kg

BIOLOGICAL

MEDI-551

1.0 mg/kg

BIOLOGICAL

MEDI-551

3.0 mg/kg

BIOLOGICAL

MEDI-551

10.0 mg/kg

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-03-31
Completion
2014-03-31

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00946699 on ClinicalTrials.gov