Overview

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 Health

Status:
Completed
Trial end date:
2016-09-28
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
MedImmune LLC
Treatments:
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Criteria
Key Inclusion Criteria:

- Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age

- Infants who are entering their first RSV season at the time of screening

Key Exclusion Criteria:

- Gestational age < 32 weeks 0 days and >34 weeks 6 days

- Meets AAP or other local criteria to receive commercial palivizumab

- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness
within 7 days prior to randomization

- Acute illness (defined as the presence of moderate or severe signs and symptoms) at
the time of randomization

- Active RSV infection (a child with signs/symptoms of respiratory infection must have
negative RSV testing) or known prior history of RSV infection

- Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination