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
Phase of Trial: Phase I/II
Latest Information Update: 27 Nov 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
- 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.