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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis

Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis

Recruiting
Phase of Trial: Phase I

Latest Information Update: 20 Dec 2018

At a glance

  • Drugs PTI 428 (Primary) ; PTI 808 (Primary) ; PTI-801 Proteostasis Therapeutics (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions
  • Sponsors Proteostasis Therapeutics
  • Most Recent Events

    • 20 Dec 2018 According to a Proteostasis Therapeutics media release, the Cystic Fibrosis Foundation (CFF) DSMB review has indicated that CF patients in the first, low-dose cohort, showed that the triple combination was generally well tolerated and dose escalation for the second cohort of the study was approved.
    • 20 Dec 2018 First cohort results were presented in a Proteostasis Therapeutics media release.
    • 20 Dec 2018 According to a Proteostasis Therapeutics media release, the company successfully completed first cohort and proceeds with higher dose testing. Also, the study remains blinded and complete efficacy and safety data is expected to be reported by Q1, 2019.
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