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Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)

5. februar 2015 oppdatert av: Biogen

Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects With Painful Lumbar Radiculopathy

The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Nederland
      • Leiden, Nederland
        • Center for Human Drug Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria: Part I and Part II

  • Healthy Volunteers

Key Inclusion Criteria: Part III multiple ascending dose (MAD)

  • Subjects must have a diagnosis of unilateral painful lumbar radiculopathy and painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit.
  • Subjects must rate their pain at ≥40 mm on the 100 mm visual analog scale (VAS) of the short form McGill pain questionnaire (SF-MPQ) at the Screening and Baseline Visits.

Key Inclusion Criteria for All Subjects for Part I, Part II, Part III:

  • All male subjects and all female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. -

Key Exclusion Criteria for All Subjects for Part I, Part II, Part III:

  • History of or positive screening test for hepatitis C infection , hepatitis B infection, or positive for human immunodeficiency virus (HIV) antibody. Subjects who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive are allowed to participate if they are positive for HBsAb immunoglobulin G
  • History of malignancy or clinically relevant (as determined by the Investigator) allergies; cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to painful lumbar radiculopathy), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
  • Relevant history of illicit drug or alcohol abuse (as defined by the Investigator) within 1 year prior to the Screening Visit. -
  • Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
  • Previous administration of a neurotrophic factor, including BG00010.
  • Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit, or current enrollment in any other study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Single Ascending Dose (SAD): BG00010
Up to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart.
Biologisk: BG00010 IV
Ascending Doses intravenous (IV) of BG00010
Andre navn:
  • Neublastin
Biologisk: BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
Andre navn:
  • Neublastin
Eksperimentell: SAD: Placebo
Up to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart.
Legemiddel: Placebo IV
Ascending Doses intravenous (IV) of Placebo
Legemiddel: Placebo SC
Ascending Doses subcutaneous (SC) of placebo
Eksperimentell: Multiple Ascending Dose (MAD): BG00010
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.
Biologisk: BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
Andre navn:
  • Neublastin
Eksperimentell: Multiple Ascending Dose (MAD): Placebo
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.
Legemiddel: Placebo SC
Ascending Doses subcutaneous (SC) of placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Tidsramme: Up to Day 75
Up to Day 75

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum observed concentration (Cmax) of BG00010
Tidsramme: Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Time to maximum serum concentration (Tmax) of BG00010
Tidsramme: Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Half life (t1/2) of BG00010
Tidsramme: Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010
Tidsramme: Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Subcutaneous (SC) bioavailability
Tidsramme: Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Number of participants with anti-BG00010 antibodies in serum
Tidsramme: Up to Day 75
Up to Day 75
Pain as measured by an 11-point numeric rating scale (NRS)
Tidsramme: Up to Day 75
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Up to Day 75
Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)
Tidsramme: Up to Day 75
A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).
Up to Day 75

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Biogen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2013

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. august 2014

Datoer for studieregistrering

Først innsendt

25. april 2013

Først innsendt som oppfylte QC-kriteriene

25. april 2013

Først lagt ut (Anslag)

29. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. februar 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 103NS103
  • 2012-005224-15 (EudraCT-nummer)

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