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Bioequivalence Randomised, Double-blind, 3-parallel -Group Phase I Study of BFI-751 Compared With EU-STELARA and US-STELARA in Healthy Adult Volunteers

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Trial Profile

Bioequivalence Randomised, Double-blind, 3-parallel -Group Phase I Study of BFI-751 Compared With EU-STELARA and US-STELARA in Healthy Adult Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Psoriasis
  • Focus First in man; Pharmacokinetics; Registrational
  • Sponsors BioFactura Australia
  • Most Recent Events

    • 11 Sep 2023 Results presented in the BioFactura Media Release.
    • 11 Sep 2023 According to BioFactura , company announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive global license to commercialize BFI-751, BioFactura's proposed biosimilar to Stelara (Ustekinumab).
    • 23 Mar 2022 Status changed from recruiting to completed.

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