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)

MedImmune

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus

Treatments: Drug: MEDI8897 10 mg; Drug: MEDI8897 50 mg; Drug: Placebo; Drug: MEDI8897 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02290340

D5290C00002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

151 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo intramuscularly.

Treatment:

Drug: Placebo

MEDI8897 10 mg

Experimental group

Description:

Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.

Treatment:

Drug: MEDI8897 10 mg

MEDI8897 25 mg

Experimental group

Description:

Participants will receive a single dose of MEDI8897 25 mg intramuscularly.

Treatment:

Drug: MEDI8897 25 mg

MEDI8897 50 mg

Experimental group

Description:

Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Treatment:

Drug: MEDI8897 50 mg