MedTrace Logo

Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers

NCT00192296 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-03-06

Study results available
· View outcomes & findings →

Summary

Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.

Conditions

Interventions

BIOLOGICAL

MEDI-528 0.3 mg/kg

MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose

BIOLOGICAL

MEDI-528 1 mg/kg

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

BIOLOGICAL

MEDI-528 3 mg/kg

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

BIOLOGICAL

MEDI-528 9 mg/kg

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Ramon Vargas, MD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-02-28
Completion
2005-03-31

Countries

  • United States

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 NCT00192296 on ClinicalTrials.gov