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A Randomized, Open-label, Single-dose, Parallel-arm, Single-center, Phase 1 Study to Determine the Bioavailability of Lanadelumab Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Subjects

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A Randomized, Open-label, Single-dose, Parallel-arm, Single-center, Phase 1 Study to Determine the Bioavailability of Lanadelumab Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Feb 2025

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At a glance

  • Drugs Lanadelumab (Primary)
  • Indications Hereditary angioedema
  • Focus Pharmacokinetics
  • Sponsors Shire; Takeda

    • Most Recent Events

    • 24 Feb 2025 According to a Takeda media release, company announced that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO(lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema (HAE). and this approval is supported by this clinical trial.
    • 09 Dec 2019 Status changed from recruiting to completed.
    • 25 Jun 2019 Status changed from not yet recruiting to recruiting.

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