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 - MEDI8897 1b

Study identifier:D5290C00002

ClinicalTrials.gov identifier:NCT02290340

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Respiratory Syncytial Virus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Placebo, MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg

Sex

All

Actual Enrollment

151

Study type

Interventional

Age

0 Months - 12 Months

Date

Study Start Date: 13 Jan 2015
Primary Completion Date: 28 Sept 2016
Study Completion Date: 28 Sept 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Sept 2018 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria