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Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults

NCT00192465 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-01-29

No results posted yet for this study

Summary

To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

MEDI-524 (Numax-TM)

Grp.1: 3 mg/kg IV (single dose)

BIOLOGICAL

MEDI-524 (Numax-TM)

Grp. 2: 15 mg/kg IV (single dose)

BIOLOGICAL

MEDI-524 (Numax-TM)

Grp. 3: 30 mg/kg IV (single dose)

BIOLOGICAL

MEDI-524 (Numax-TM)

Grp. 4: 3 mg/kg IM (single dose)

BIOLOGICAL

MEDI-524 (Numax-TM)

Grp.5: 3 mg/kg IM (two doses)

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Genevieve Losonsky, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2004-04-30
Completion
2004-11-30

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 NCT00192465 on ClinicalTrials.gov