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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers

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Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Nov 2024

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At a glance

  • Drugs Nintedanib (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Adverse reactions; First in man
  • Sponsors MannKind Corporation

    • Most Recent Events

    • 04 Nov 2024 Status changed from recruiting to completed, according to a MannKind Corporation media release.
    • 04 Nov 2024 Results presented in the MannKind Corporation Media Release.
    • 04 Nov 2024 According to a MannKind Corporation media release, company announced the successful completion of its first-in-human study in nintedanib. Company looks forward to discussing the Phase 1 trial results and our proposed late-stage development program at an end of phase 1 meeting with the FDA, planned for the first half of 2025.

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