Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory Syncytial Virus, RSV
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 151
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
measure: Number of Participants With Treatment-Emergent Adverse Events of Special Interest
timeFrame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
timeFrame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
Secondary outcomes:
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
measure: Maximum Observed Serum Concentration (Cmax) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
measure: Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
measure: Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
measure: Terminal Elimination Half Life (t1/2) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
measure: Extravascular Clearance (CL/F) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
measure: Extravascular Volume of Distribution (Vz/F) of MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
measure: Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
timeFrame: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Ontario
country: United States
facility: Research Site
state: California
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Saint George
country: United States
facility: Research Site
state: Utah
city: Marshfield
country: United States
facility: Research Site
state: Wisconsin
city: Santiago
country: Chile
facility: Research Site
city: Valdivia
country: Chile
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: East London
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
Study officials:
References: