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A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI 808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

Trial Profile

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI 808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2019

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At a glance

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

    • 14 Jun 2019 Phase changed from 1 to 1/2, Number of arm changed form 12 to 15, Part 4 added, where CF subjects who are either homozygous for the F508del CFTR genotype or are heterozygous for the F508del CFTR genotype will be enrolled. Planned patient number changed from 135 to 180.
    • 14 Jun 2019 Planned number of patients changed from 135 to 180.
    • 14 Jun 2019 Planned End Date changed from 1 Jun 2019 to 1 Jan 2020.
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