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A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive

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Trial Profile

A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Feb 2026

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Unspecified
  • Focus Pharmacokinetics; Registrational
  • Sponsors Alvotech

Most Recent Events

  • 05 Feb 2026 According to an Alvotech Media Release, based on regulatory advice, the AVT80-GL-P01 clinical study is considered pivotal to support the demonstration of clinical similarity for AVT16 and AVT80.
  • 05 Feb 2026 Primary endpoint has been met. (To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio), according to an Alvotech Media Release.
  • 05 Feb 2026 Primary endpoint has been met. (To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio), according to an Alvotech Media Release.

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