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

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.

Timeline

Start

2026-06

Primary completion

2026-06

Completion

2026-06

Outcome

Outcome not reported

Stopped: “Study did not start”

Drugs

Indications