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SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Sponsor: Sound Pharmaceuticals, Incorporated
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.
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2017-07-21
Completion Date
2023-04-07
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
Placebo
0 mg SPI-1005 bid po x 21d
SPI-1005 Ebselen 200mg Capsule x1
200 mg SPI-1005 bid po x21d
SPI-1005 Ebselen 200mg Capsule x2
400 mg SPI-1005 bid po x 21d
SPI-1005 Ebselen 200mg Capsule x3
600 mg SPI-1005 bid po x 21d
Locations (1)
Medical University of South Carolina
Charleston, South Carolina, United States