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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sound Pharmaceuticals, Incorporated
• Treatments: Ebselen

Criteria

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