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A Randomized, Double-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics (PK), Safety and Immunogenicity Profile of MB04 (proposed Etanercept Biosimilar), EU-sourced Enbrel and US Licensed Enbrel in Healthy Male Volunteers

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Trial Profile

A Randomized, Double-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics (PK), Safety and Immunogenicity Profile of MB04 (proposed Etanercept Biosimilar), EU-sourced Enbrel and US Licensed Enbrel in Healthy Male Volunteers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2024

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At a glance

  • Drugs Etanercept (Primary)
  • Indications Autoimmune disorders
  • Focus Pharmacokinetics
  • Sponsors mAbxience

    • Most Recent Events

    • 24 Sep 2024 Planned End Date changed from 1 Sep 2024 to 1 Dec 2024.
    • 31 Jul 2024 Planned End Date changed from 1 Aug 2024 to 1 Sep 2024.
    • 31 Jul 2024 Planned primary completion date changed from 1 Aug 2024 to 1 Sep 2024.

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