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An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of the Intravenous Formulation of Guselkumab Using Prefilled Syringes Assembled in an UltraSafe Plus Passive Needle Guard and Intravenous Formulation of Guselkumab Using Final Vialed Product in Healthy Participants

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Trial Profile

An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of the Intravenous Formulation of Guselkumab Using Prefilled Syringes Assembled in an UltraSafe Plus Passive Needle Guard and Intravenous Formulation of Guselkumab Using Final Vialed Product in Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Sep 2021

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At a glance

  • Drugs Guselkumab (Primary)
  • Indications Crohn's disease; Erythrodermic psoriasis; Familial adenomatous polyposis; Hidradenitis suppurativa; Lupus nephritis; Palmoplantar pustulosis; Plaque psoriasis; Psoriasis; Psoriatic arthritis; Pustular psoriasis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 25 Aug 2021 Status changed from recruiting to completed.
    • 24 Dec 2020 Status changed from not yet recruiting to recruiting.
    • 24 Nov 2020 Planned initiation date changed from 3 Nov 2020 to 30 Nov 2020.
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