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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 Clofazimine Inhalation Suspension (MNKD-101) 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 Clofazimine Inhalation Suspension (MNKD-101) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Jan 2023

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At a glance

  • Drugs Clofazimine (Primary)
  • Indications Nontuberculous mycobacterium infections; Tuberculosis
  • Focus Adverse reactions; First in man
  • Sponsors MannKind Corporation
  • Most Recent Events

    • 23 Jan 2023 Results published in the MannKind Corporation Media Release.
    • 06 Sep 2022 According to a MannKind Corporation media release, detailed data findings from the trial will be presented in upcoming publications and scientific conferences.
    • 06 Sep 2022 According to a MannKind Corporation media release, the company is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results of this trial and the ongoing clinical program
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