Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
10. september 2021 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 2 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andre navne:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andre navne:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andre navne:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andre navne:
|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Genevieve A Losonsky, MD, MedImmune LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2004
Primær færdiggørelse (Faktiske)
1. januar 2005
Studieafslutning (Faktiske)
1. januar 2005
Datoer for studieregistrering
Først indsendt
13. september 2005
Først indsendt, der opfyldte QC-kriterier
13. september 2005
Først opslået (Skøn)
19. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. oktober 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2021
Sidst verificeret
1. oktober 2006
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MI-CP106
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