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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)

18. September 2018 aktualisiert von: MedImmune LLC
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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

151

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Chile
      • Santiago, Chile
        • Research Site
      • Valdivia, Chile
        • Research Site
  • Südafrika
      • Cape Town, Südafrika
        • Research Site
      • East London, Südafrika
        • Research Site
      • Johannesburg, Südafrika
        • Research Site
      • Pretoria, Südafrika
        • Research Site
  • Vereinigte Staaten
    • California
      • Anaheim, California, Vereinigte Staaten
        • Research Site
      • Ontario, California, Vereinigte Staaten
        • Research Site
    • New York
      • Syracuse, New York, Vereinigte Staaten
        • Research Site
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten
        • Research Site
    • Utah
      • Saint George, Utah, Vereinigte Staaten
        • Research Site
    • Wisconsin
      • Marshfield, Wisconsin, Vereinigte Staaten
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Nicht älter als 1 Jahr (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Participants will receive placebo intramuscularly.
Arzneimittel: Placebo
Participants will receive placebo intramuscularly.
Experimental: MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
Arzneimittel: MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
Experimental: MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
Arzneimittel: MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
Experimental: MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
Arzneimittel: MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Zeitfenster: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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.
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Zeitfenster: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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.
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
Zeitfenster: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
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.
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Maximum Observed Serum Concentration (Cmax) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
The Cmax is the maximum observed serum concentration of MEDI8897.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Terminal Elimination Half Life (t1/2) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Extravascular Clearance (CL/F) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Extravascular Volume of Distribution (Vz/F) of MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
Zeitfenster: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive.
Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

MedImmune LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Januar 2015

Primärer Abschluss (Tatsächlich)

28. September 2016

Studienabschluss (Tatsächlich)

28. September 2016

Studienanmeldedaten

Zuerst eingereicht

17. Oktober 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. November 2014

Zuerst gepostet (Schätzen)

14. November 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. September 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D5290C00002

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