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A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

23. juni 2014 opdateret af: MedImmune LLC

A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

125

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 18 years up to and including 49 years at the time of first dose of investigational product
  • Healthy by medical history, physical examination, and laboratory studies
  • Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m^2) (inclusive)
  • Females must be of non-childbearing potential.

Exclusion criteria:

  • Any acute illness within 30 days of screening
  • Concurrent enrollment in another clinical trial
  • The subject has a positive drug/alcohol screen at screening or Day -1
  • Pregnancy
  • Current cigarette smokers
  • History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success
  • Use of immunosuppressive medications
  • Subjects who have an unresolved infection with any Neisseria species
  • Subjects who have had their spleen removed for any reason.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
Andet: Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
Eksperimentel: MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
Biologisk: MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Eksperimentel: MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Biologisk: MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Eksperimentel: MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Biologisk: MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Eksperimentel: MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Biologisk: MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tidsramme: Day 1 to Day 106
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Day 1 to Day 106

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetic (PK) Parameters of MEDI7814
Tidsramme: Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106
Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.
Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106
Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814
Tidsramme: Day 1, 29, 57, 85, and 106
Day 1, 29, 57, 85, and 106

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

MedImmune LLC

Efterforskere

  • Ledende efterforsker: Alan Marion, MD, Research Site

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. januar 2012

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

15. februar 2012

Først indsendt, der opfyldte QC-kriterier

2. marts 2012

Først opslået (Skøn)

5. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CD-RI-MEDI7814-1027

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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