Conditions: Respiratory Syncytial Virus
Keywords: Respiratory Syncytial Virus, RSV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Participants will receive placebo intramuscularly. arm 2: Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly. arm 3: Participants will receive a single dose of MEDI8897 25 mg intramuscularly. arm 4: Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Interventions: intervention 1: Placebo intervention 2: MEDI8897 10 mg intervention 3: MEDI8897 25 mg intervention 4: MEDI8897 50 mg
Intervention descriptions: intervention 1: Participants will receive placebo intramuscularly. intervention 2: Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly. intervention 3: Participants will receive a single dose of MEDI8897 25 mg intramuscularly. intervention 4: Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Protocol document: