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A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557

NCT00578682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-11-23

No results posted yet for this study

Summary

To evaluate the safety and tolerability of a single IV dose of MEDI-557.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MEDI-557

Single IV dose of 3 mg/kg

BIOLOGICAL

MEDI-557

Single IV dose of 15 mg/kg

BIOLOGICAL

MEDI-557

Single IV dose of 30 mg/kg

BIOLOGICAL

MEDI-557

Single IV dose of 0.3 mg/kg

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • M. Pamela Griffin, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-10-31
Completion
2010-11-30

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 NCT00578682 on ClinicalTrials.gov