Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

21. april 2015 opdateret af: Pfizer

A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • LDL-C must be greater or equal to 130 mg/dl
  • BMI must be between 18.5 and 40 kg/m2

Exclusion Criteria:

  • History of cardiovascular or cerebrovascular event during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus
  • Subjects who have taken lipid lowering therapies within the last 3 months of screening.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Biologisk: Placebo
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Eksperimentel: RN316: 1 mg/kg every 2 weeks
Biologisk: 1 mg/kg every 2 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Eksperimentel: RN316: 2 mg/kg every 4 weeks
Biologisk: 2 mg/kg every 4 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Eksperimentel: RN316: 4 mg/kg every 4 weeks
Biologisk: 4 mg/kg every 4 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Eksperimentel: RN316: 4 mg/kg every 8 weeks
Biologisk: 4 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Eksperimentel: RN316: 8 mg/kg every 8 weeks
Biologisk: 8 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Eksperimentel: RN316: 12 mg/kg every 8 weeks
Biologisk: 12 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of dose limiting or intolerable treatment related adverse events (AEs).
Tidsramme: Every Scheduled Visit
Every Scheduled Visit
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
Tidsramme: Every Scheduled Visit
Every Scheduled Visit
Incidence of abnormal and clinically relevant safety laboratories.
Tidsramme: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
Tidsramme: Every Scheduled Visit
Every Scheduled Visit
Incidence of anti-drug-antibodies.
Tidsramme: Baseline and Day 15 and monthly thereafter
Baseline and Day 15 and monthly thereafter

Sekundære resultatmål

Resultatmål
Tidsramme
PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316.
Tidsramme: Day 1 and every scheduled visit thereafter
Day 1 and every scheduled visit thereafter
Absolute and percentage change in LDL C from baseline.
Tidsramme: Every scheduled visit except Day 1
Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <100 mg/mL.
Tidsramme: Every scheduled visit except Day 1
Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <70 mg/dL.
Tidsramme: Every scheduled visit except Day 1
Every scheduled visit except Day 1
Proportion of subjects achieving 50% decrease in LDL C from baseline.
Tidsramme: Every scheduled visit except Day 1
Every scheduled visit except Day 1

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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. august 2010

Primær færdiggørelse (Forventet)

1. marts 2011

Studieafslutning (Forventet)

1. marts 2011

Datoer for studieregistrering

Først indsendt

14. juli 2010

Først indsendt, der opfyldte QC-kriterier

15. juli 2010

Først opslået (Skøn)

16. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B1481002

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 .

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner