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Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

10 settembre 2021 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 2 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Motavizumab, 3 mg/kg as a single intravenous dose
Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Sperimentale: Motavizumab, 15 mg/kg as a single intravenous dose
Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Sperimentale: Motavizumab, 30 mg/kg as a single intravenous dose
Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Biologico: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Altri nomi:
  • MEDI-524
Comparatore placebo: Placebo, as a single intravenous dose
Placebo, as a single intravenous dose administered on Day 0
Altro: Placebo
Single dose of placebo administered intravenously (in the vein) on Day 0

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

MedImmune LLC

Investigatori

  • Direttore dello studio: Genevieve A Losonsky, MD, MedImmune LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2004

Completamento primario (Effettivo)

1 gennaio 2005

Completamento dello studio (Effettivo)

1 gennaio 2005

Date di iscrizione allo studio

Primo inviato

13 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2005

Primo Inserito (Stima)

19 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 ottobre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2021

Ultimo verificato

1 ottobre 2006

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MI-CP106

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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