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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528

NCT00116168 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-12-11

Study results available
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Summary

A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MEDI-528 0.3 mg/kg

MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose

BIOLOGICAL

MEDI-528 1 mg/kg

MEDI-528 (1 mg/kg) administered as a single, SC dose

BIOLOGICAL

MEDI-528 3 mg/kg

MEDI-528 (3 mg/kg) administered as a single, SC dose

BIOLOGICAL

MEDI-528 9 mg/kg

MEDI-528 (9 mg/kg) administered as a single, SC dose

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Barbara White, M.D. · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-04-30
Completion
2006-07-31

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 NCT00116168 on ClinicalTrials.gov