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

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)

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.

Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.

Inclusion Criteria:

• Adult male or female patients, 18-50 years of age
• History of either recreational and/or occupational exposure to noise
• Voluntarily consent to participate in the study
• Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
• Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria:

• Current use or within 60 days prior to study of excluded ototoxic medications
• History of autoimmune inner ear disease
• History of middle ear or inner ear surgery
• Current conductive hearing loss or middle ear effusion
• Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen
• Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
• Participation in another investigational drug or device study within 90 days prior to study enrollment
• Female patients who are pregnant or breastfeeding