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



Status:Not yet recruiting
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:8/26/2018
Start Date:November 2018
End Date:October 2021
Contact:Jonathan Kil, MD
Email:jkil@soundpharma.com
Phone:2066342559

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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
We found this trial at
5
sites
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Charleston, South Carolina 29425
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Dallas, Texas 75390
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Seattle, Washington 98103
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Seattle, WA
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