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A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis

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Trial Profile

A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Nesolicaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; First in man
  • Sponsors Proteostasis Therapeutics

    • Most Recent Events

    • 23 May 2018 Results assessing the relationship between nasal CFTR protein levels with lung function changes in response to lumacaftor-ivacaftor treatment for Phe508del homozygous CF patients, presented at the 114th International Conference of the American Thoracic Society
    • 20 Mar 2018 According to a Proteostasis Therapeutics media release, based on the data from this trial, triple combination study (see profile 292094 ) protocol received endorsement and a high strategic fit score from the Therapeutics Development Network (TDN) and the Clinical Trial Network (CTN) in January 2018.
    • 14 Mar 2018 Results published in the Proteostasis Therapeutics media release.
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