A PHASE 1b, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS and PHARMACODYNAMICS OF SPI-1005 in CYSTIC FIBROSIS (CF) PATIENTS WITH ACTIVE PULMONARY EXACERBATION RECEIVING IV TOBRAMYCIN

Trial Profile

A PHASE 1b, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS and PHARMACODYNAMICS OF SPI-1005 in CYSTIC FIBROSIS (CF) PATIENTS WITH ACTIVE PULMONARY EXACERBATION RECEIVING IV TOBRAMYCIN

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 May 2017

At a glance

  • Drugs Ebselen (Primary)
  • Indications Meniere's disease; Sensorineural hearing loss; Tinnitus; Vertigo
  • Focus Adverse reactions
  • Acronyms STOP Ototoxicity
  • Sponsors Sound Pharmaceuticals
  • Most Recent Events

    • 15 May 2017 Status changed from not yet recruiting to recruiting.
    • 15 May 2017 Planned End Date changed from 1 Jun 2018 to 1 Dec 2018.
    • 15 May 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Aug 2018.
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