SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

May 31, 2026 updated by: Sound Pharmaceuticals, Incorporated

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity

The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.

The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics of SPI-1005.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of SPI-1005 in Cystic Fibrosis patients with Acute Pulmonary Exacerbation receiving intravenous tobramycin at risk for ototoxicity. All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
  • 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 IUD 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.
  • Ability to perform all behavioral tests as indicated.

Exclusion Criteria:

  • Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
  • History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
  • History of middle ear or inner ear surgery.
  • Current conductive hearing loss or middle ear effusion.
  • Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
  • History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
  • Participation in another investigational drug or device study within 30 days prior to study enrollment.
  • Female patients who are pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: SPI-1000 Capsule 0mg Ebselen Placebo
0mg Ebselen SPI-1000 bid po x 21d
Drug: Placebo
0 mg SPI-1005 bid po x 21d
Other Names:
  • SPI-1000
Experimental: SPI-1005 Ebselen 200mg Capsule x1
200mg SPI-1005 bid po x 21d Low Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x1
200 mg SPI-1005 bid po x21d
Other Names:
  • SPI-1005 Low Dose
Experimental: SPI-1005 Ebselen 200mg Capsule x2
400mg SPI-1005 bid po x 21d Mid Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x2
400 mg SPI-1005 bid po x 21d
Other Names:
  • SPI-1005 Mid Dose
Experimental: SPI-1005 Ebselen 200mg Capsule x3
600mg SPI-1005 bid po x 21d High Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x3
600 mg SPI-1005 bid po x 21d
Other Names:
  • SPI-1005 High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensorineural Hearing Loss Using Pure-tone Audiometry
Time Frame: 4 weeks post-tobramycin
Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.
4 weeks post-tobramycin
Distortion Product Otoacoustic Emissions
Time Frame: 4 weeks post-tobramycin
Number of participants with ototoxicity: Decreases in Distortion Product Otoacoustic Emissions (DPOAE), defined as a greater than or equal to 5 dB decrease in DPOAE amplitude in at least one test frequency.
4 weeks post-tobramycin
Speech Discrimination
Time Frame: 4 weeks post-tobramycin
Number of participants with ototoxicity: Decreases in speech discrimination using the Words in Noise test (WIN) score (0-35, where higher scores are a better outcome), defined as a 10% or greater decrease in WIN score from participant's baseline score.
4 weeks post-tobramycin
Tinnitus Severity
Time Frame: 4 weeks post-tobramycin
Number of participants with ototoxicity: Increases in Tinnitus Functional Index (TFI) score (0-100, where higher scores are a worse outcome), defined as an increase of 10 points or more from baseline.
4 weeks post-tobramycin
Vertigo Severity
Time Frame: 4 weeks post-tobramycin
Number of participants with vestibulotoxicity: Increases in Vertigo Symptom Scale - Short Form score (0-60, where higher scores are a worse outcome), defined as an increase of 6 points or more from baseline.
4 weeks post-tobramycin
Changes in Lung Function
Time Frame: 4 weeks post-tobramycin
Evaluation of lung function using spirometry, assessed using the change from baseline in Forced Expiratory Volume in 1 second (FEV1).
4 weeks post-tobramycin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacogenomics
Time Frame: 5 weeks
Pharmacogenomics analysis will explore SPI-1005 as an inducer of gene expression for Nrf2, glutathione peroxidase-1, hemeoxygenase-1, and thioredoxin class of redox proteins.
5 weeks
Pharmacodynamics of Nrf2
Time Frame: 5 weeks
Explore SPI-1005 on the level of Nrf2 by PCR
5 weeks
Pharmacodynamics of Glutathione, cysteine and cystine
Time Frame: 5 weeks
Explore SPI-1005 on the level of Glutathione, cysteine and cystine measured in µM.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Pharmaceuticals, Incorporated

Collaborators

Medical University of South Carolina
Cystic Fibrosis Foundation

Investigators

  • Study Chair: Jonathan Kil, MD, Sound Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2017

Primary Completion (Actual)

April 7, 2023

Study Completion (Actual)

April 7, 2023

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-3005-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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