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A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

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Trial Profile

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Asthma; Chronic urticaria
  • Focus Pharmacokinetics
  • Sponsors Celltrion

    • Most Recent Events

    • 16 May 2023 According to a Celltrion Media Release,Celltrion plans to further strengthen its core businesses and is preparing market authorization for CT-P39.
    • 28 Feb 2022 Results presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 13 Sep 2021 Status changed from recruiting to completed.

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