NCT02290340

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Detailed description

This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-13
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2014-11-14
• Last updated: 2018-09-19
• Results posted: 2018-09-19

Locations

13 sites across 3 countries: United States, Chile, South Africa