A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

PHASE1CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

January 13, 2015

Primary Completion Date

September 28, 2016

Study Completion Date

September 28, 2016

Conditions
Respiratory Syncytial Virus
Interventions
DRUG

Placebo

Participants will receive placebo intramuscularly.

DRUG

MEDI8897 10 mg

Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.

DRUG

MEDI8897 25 mg

Participants will receive a single dose of MEDI8897 25 mg intramuscularly.

DRUG

MEDI8897 50 mg

Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Trial Locations (13)

Unknown

Research Site, Anaheim

Research Site, Ontario

Research Site, Syracuse

Research Site, Cleveland

Research Site, Charleston

Research Site, St. George

Research Site, Marshfield

Research Site, Santiago

Research Site, Valdivia

Research Site, Cape Town

Research Site, East London

Research Site, Johannesburg

Research Site, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY