Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
10. September 2021 aktualisiert von: MedImmune LLC
A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
31
Phase
- Phase 1
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 2 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Previously healthy
- Age 24 months and younger at the time of randomization
- Gestational age of 36 weeks gestation and older
- Randomization within 24 hours after hospitalization
- Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization
Exclusion Criteria:
- Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
- Required intubation for ventilatory support
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
- Mechanical ventilation at any time prior to the onset of the current RSV infection
- Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
- Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
- Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
- Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Motavizumab, 3 mg/kg as a single intravenous dose
Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
|
|
Experimental: Motavizumab, 15 mg/kg as a single intravenous dose
Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
|
|
Experimental: Motavizumab, 30 mg/kg as a single intravenous dose
Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andere Namen:
|
|
Placebo-Komparator: Placebo, as a single intravenous dose
Placebo, as a single intravenous dose administered on Day 0
|
Single dose of placebo administered intravenously (in the vein) on Day 0
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Zeitfenster: From the start of treatment to 30 days after dosing
|
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
|
From the start of treatment to 30 days after dosing
|
|
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
Zeitfenster: From the start of treatment to 30 days after dosing
|
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
|
From the start of treatment to 30 days after dosing
|
|
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
Zeitfenster: From the start of treatment to 30 days after dosing
|
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
|
From the start of treatment to 30 days after dosing
|
|
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
Zeitfenster: Day 2 and Day 30
|
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30.
Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
|
Day 2 and Day 30
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
Zeitfenster: Immediately before dosing on Day 0
|
The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing).
Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
|
Immediately before dosing on Day 0
|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
Zeitfenster: Day 30
|
The serum anti-motavizumab antibody titers were measured in subjects on Day 30.
Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
|
Day 30
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Genevieve A Losonsky, MD, 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
1. März 2004
Primärer Abschluss (Tatsächlich)
1. Januar 2005
Studienabschluss (Tatsächlich)
1. Januar 2005
Studienanmeldedaten
Zuerst eingereicht
13. September 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. September 2005
Zuerst gepostet (Schätzen)
19. September 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Oktober 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. September 2021
Zuletzt verifiziert
1. Oktober 2006
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MI-CP106
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