Recruiting
Phase 2

SPI-1005

Sponsor:

Sound Pharmaceuticals, Incorporated

Code:

NCT06340633

Conditions

Hearing Loss

Cochlear Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ebselen

Placebo

Study Details

Brief summary:

The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.

The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?

The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.

Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.

The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.

Conditions

Hearing Loss

Cochlear Trauma

Study ID

NCT06340633

Start date

Dec, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults who are ≥18 years of age at time of consent.
  • Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
  • Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:

  • ≤70 dB HL at 125, 250, and 500 Hz; AND
  • ≥70 dB HL at 2000, 4000, and 8000 Hz.
  • Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.
  • Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.

Exclusion Criteria:

  • Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
  • Participation in another investigational drug or device study within 90 days prior to study consent.
  • Female patients who are pregnant or breastfeeding.
  • Moderate or severe hepatic impairment using Child-Pugh Score (>6 points).
  • No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.
  • No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SPI-1005 400 mg twice daily (BID)

Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days

placebo comparator: Placebo

Oral administration of matching placebo BID for 180 days

Interventions

Ebselen

Glutathione peroxidase mimetic

Placebo

Matching placebo containing excipients

Primary outcome measure

  • Number of Participants with Treatment Emergent Adverse Events (TEAE) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jonathan Kil, MD

2066342559info@soundpharma.com

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Lead Clinical Research Coordinator

319-356-8320kesten-anderson@uiowa.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Beth Miles-Markley

614-366-9244beth.miles-markley@osumc.edu

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Morgan Kyser

(215) 955-6760morgan.kyser@jefferson.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Research Director

(843)792-1356nguyensh@musc.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Paula Arellano-Cruz

214-648-8096paula.arellano-cruz@utsouthwestern.edu

More Information

Sponsor

Sound Pharmaceuticals, Incorporated

Last update posted

Jun 26, 2026

Last verified

May, 2026

Keywords

  • Hearing Preservation
  • Cochlear Implant
  • SPI-1005
  • Ebselen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sound Pharmaceuticals, Incorporated on 2026-06-26.