A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Status:
Unknown status
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
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.