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

Study identifier:MI-CP144

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomized, Double-Blind, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557, A Humanized Monoclonal Antibody with an Extended Half-Life against Respiratory Syncytial Virus (RSV), in Healthy Adults

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

31

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Dec 2007
Primary Completion Date: 01 Oct 2010
Study Completion Date: 01 Nov 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2011 by MedImmune

Sponsors

MedImmune

Collaborators

-

Inclusion and exclusion criteria