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WITHDRAWN
NCT02779192
PHASE2

A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

Sponsor: Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

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

Interventions

DRUG

SPI-1005 200mg

Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days

DRUG

SPI-1005 400mg

Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days

DRUG

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