Overview

This trial has been completed.

Condition respiratory syncytial virus
Treatments medi8897, placebo
Phase phase 1
Sponsor MedImmune LLC
Start date January 2015
End date September 2016
Trial size 151 participants
Trial identifier NCT02290340, D5290C00002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Anti-RSV monoclonal antibody with an extended half-life.
medi8897
Anti-RSV monoclonal antibody with an extended half-life.
(Placebo Comparator)
Solution containing no active ingredients
placebo
Solution containing no active ingredients.

Primary Outcomes

Measure
The occurence of Adverse Events and Serious Adverse Events
time frame: 360 days post dose
The occurence of abnormal laboratory assessments.
time frame: 150 days post dose
The occurence of abnormal laboratory assessments
time frame: 150 days post dose

Secondary Outcomes

Measure
Pharmacokinetics of MEDI8897 in serum: terminal-phase elimination (t½)
time frame: 360 days post dose
Pharmacokinetics of MEDI8897 in serum: extravascular systemic clearance (CL/F)
time frame: 360 days post dose
Incidence of anti-drug antibody to MEDI8897 in serum
time frame: 360 days post dose

Eligibility Criteria

Male or female participants up to 12 months old.

Inclusion Criteria: Subjects must meet all of the following criteria: 1. Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age 2. Infants who are entering their first RSV season at the time of screening. 3. Subject's parent(s)/legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator 4. Subject's parent(s)/legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol Exclusion Criteria: Any of the following would exclude the subject from participation in the study: 1. Gestational age < 32 weeks 0 days and >34 weeks 6 days 2. Meets AAP or other local criteria to receive commercial palivizumab 3. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization 4. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization 5. Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination 6. Any of the following laboratory findings in blood obtained within 7 days prior to study entry: - Blood urea nitrogen (BUN) or creatinine >1.5 × the upper limit of normal for age - Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 × the upper limit of normal for age - Hemoglobin < 9.5 gm/dL - White blood cell count < 4,000 cells/mm3 - Platelet count < 120,000 cells/mm3

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by MedImmune LLC.