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A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Sponsor: Sound Pharmaceuticals, Incorporated
Summary
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Official title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2026-06
Completion Date
2026-06
Last Updated
2026-06-03
Healthy Volunteers
Yes
Conditions
Interventions
SPI-1005 200mg
Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
SPI-1005 400mg
Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
Placebo
Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days
Locations (5)
University of Miami
Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
MUSC
Charleston, South Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
Sound Pharmaceuticals, Inc.
Seattle, Washington, United States