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An Open Label, Randomized, Parallel Group Study to Evaluate the Pharmacokinetics of Tezepelumab Administered Subcutaneously Via Accessorized Pre Filled Syringe (APFS) or Autoinjector (AI) Compared With Vial and Syringe in Healthy Adult Subjects (PATH-BRIDGE)

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Trial Profile

An Open Label, Randomized, Parallel Group Study to Evaluate the Pharmacokinetics of Tezepelumab Administered Subcutaneously Via Accessorized Pre Filled Syringe (APFS) or Autoinjector (AI) Compared With Vial and Syringe in Healthy Adult Subjects (PATH-BRIDGE)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Feb 2023

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At a glance

  • Drugs Tezepelumab (Primary)
  • Indications Asthma; Atopic dermatitis; Chronic obstructive pulmonary disease
  • Focus Pharmacokinetics
  • Acronyms PATH-BRIDGE
  • Sponsors AstraZeneca

Most Recent Events

  • 02 Feb 2023 According to an AstraZeneca media release, TEZSPIRE (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. This approval was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trials.
  • 02 Feb 2023 According to AstraZeneca media release, the company has received the approval from U.S. FDA for self-administration of drug in pre-filled, single use pen for patients aged 12 years and older with severe asthma. The approval was based on the results from this study.
  • 12 Jan 2023 According to AstraZeneca media release, the company has received a positive opinion from the European Medicine Agency's Committee for medicinal products for human use (CHMP) for self-administration in a pre-filled, single use pen for patients aged 12 years and older with severe asthma. This approval was based on the results from this study.

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