SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Status:
Enrolling by invitation
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to determine the safety and efficacy of SPI-1005
treatment in CF patients with active pulmonary exacerbation that are receiving an IV course
of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK),
Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.
The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics
of SPI-1005.
Phase:
Phase 2
Details
Lead Sponsor:
Sound Pharmaceuticals, Incorporated
Collaborators:
Cystic Fibrosis Foundation Cystic Fibrosis Foundation Therapeutics Medical University of South Carolina