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