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A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers

25. april 2014 opdateret af: Biogen

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Ranging, Parallel-Group Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Volunteers

The primary objectives are to identify the highest safe and well-tolerated dose and frequency of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188 mcg, when given every other week or every 4 weeks to healthy volunteers (HV).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

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 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

  • Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive, and a minimum body weight of 50.0 kg at screening.
  • All male subjects and female subjects of child-bearing potential must be willing and able to practice effective birth control during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Key Exclusion Criteria:

  • Abnormal screening and baseline blood and urine tests determined to be clinically significant by the Investigator.
  • Hematologic or hepatic enzyme laboratory values that were outside the normal range.
  • History of severe allergic or anaphylactic reactions.
  • History of any clinically-significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, and/or history of seizure disorder.
  • A family history of MS in a first-degree relative.
  • A fever (body temperature >38°C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to Day 1.
  • Abnormal ECG values as determined by the Investigator.
  • Positive test result for hepatitis C antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody.
  • Female subjects who are considering pregnancy, currently pregnant or breastfeeding.
  • Subjects who received a tattoo or body piercing (including earring) within 60 days of baseline or subjects who are considering getting a tattoo or body piercing (including earring) in the next 60 days.
  • Use of any prescription or non-prescription medication that could inhibit bone marrow or liver function.
  • Any previous treatment with any interferon product.
  • Participation in any other investigational drug study within the 4 weeks prior to Day 1 or within 5 half-lives of the investigational treatment, whichever is longer.
  • Treatment with the Flu Vaccine within 1 week prior to Day 1.

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

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: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BIIB017 (PEGylated Interferon Beta-1a)
Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every other week for a total of 6 weeks.
Medicin: BIIB017 (PEGylated Interferon Beta-1a)
Each participant will receive BIIB017 every other week or every 4 weeks.
Eksperimentel: BIIB017 (PEGylated Interferon Beta-1a) and Placebo
Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every 4 weeks for a total of 6 weeks. To ensure blinding, each subject will receive placebo every other week.
Medicin: BIIB017 (PEGylated Interferon Beta-1a)
Each participant will receive BIIB017 every other week or every 4 weeks.
Medicin: Placebo
Each participant will receive placebo every other week or every 4 weeks.
Placebo komparator: Placebo
Placebo dose will be administered SC every other week for a total of 6 weeks.
Medicin: BIIB017 (PEGylated Interferon Beta-1a)
Each participant will receive BIIB017 every other week or every 4 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The number of participants that experience Adverse Events (AEs)
Tidsramme: Up to Day 71
Up to Day 71
The number of participants that experience flu-like symptoms
Tidsramme: Up to Day 71
Up to Day 71
Participant assessment of injection site pain as measured by scores on a scale of 0 to 10, where 0 is no pain and 10 is extremely painful.
Tidsramme: Up to Day 71
Up to Day 71
Clinician assessment of the injection site for erythema as assessed by a scale 0 to 3, where 0 represents no erythema and 3 represents severe erythema
Tidsramme: Up to Day 71
Up to Day 71
Clinician assessment of the injection site for induration as assessed by a scale 0 to 3, where 0 represents no induration and 3 represents severe induration
Tidsramme: Up to Day 71
Up to Day 71
Clinician assessment of tenderness to digital pressure at the injection site will be assessed on a scale of 0 to 3, where 0 represents no tenderness and 3 represents severe tenderness
Tidsramme: Up to Day 71
Up to Day 71
Clinician assessment of temperature at the injection site will be assessed on a scale of 0 to 2, where 0 represents normal temperature and 2 represents hot.
Tidsramme: Up to Day 71
Up to Day 71

Sekundære resultatmål

Resultatmål
Tidsramme
AUC168h, area under the concentration-time curve
Tidsramme: Up to 168 hours post dose
Up to 168 hours post dose
Cmax, observed maximum serum concentration
Tidsramme: Up to 336 hours post-dose
Up to 336 hours post-dose
Tmax, time to reach maximum serum concentration
Tidsramme: Up to 336 hours post-dose
Up to 336 hours post-dose
Terminal t½, half-life of the terminal phase
Tidsramme: Up to 336 hours post-dose
Up to 336 hours post-dose
EAUC-336h, area under the concentration-time curve from time zero to 336 hours post-dose
Tidsramme: Up to 336 hours post-dose
Up to 336 hours post-dose
Emax, the peak concentration observed minus baseline concentration
Tidsramme: Day 1 and Day 29
Day 1 and Day 29
PD parameters of serum concentrations of neopterin
Tidsramme: Day 1 and Day 29
Day 1 and Day 29

Samarbejdspartnere og efterforskere

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

Sponsor

Biogen

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.

Generelle publikationer

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 2008

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

25. april 2014

Først indsendt, der opfyldte QC-kriterier

25. april 2014

Først opslået (Skøn)

29. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 105HV102

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 BIIB017 (PEGylated Interferon Beta-1a)

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner