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

MedImmune LLC151 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

151

Conditions

Respiratory Syncytial Virus

Interventions

PlaceboDRUG

Participants will receive placebo intramuscularly.

MEDI8897 10 mgDRUG

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

MEDI8897 25 mgDRUG

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

Eligibility

Sex: ALLMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (13)

Research Site

Anaheim, California, United States

Research Site

Ontario, California, United States

Research Site

Syracuse, New York, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)

Number of Participants With Treatment-Emergent Adverse Events of Special Interest

An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.

Time frame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)

Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events

Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.

Time frame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)

Secondary Outcomes

Data from ClinicalTrials.gov

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Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897

The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.