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

(PANIHL Trial)

Recruiting at 4 trial locations

Overseen By Jonathan Kil, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Sound Pharmaceuticals, Incorporated

Must not be taking: Ototoxic medications, Cytochrome P450

Disqualifiers: Autoimmune ear disease, Ear surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests SPI-1005, a new pill designed to protect the ears, in adults who have already suffered hearing loss from loud noises. The drug works by mimicking a natural enzyme that helps reduce further hearing damage. SPI-1005, also known as ebselen, is an anti-inflammatory and neuroprotective drug that has shown efficacy in reducing noise-induced and aminoglycoside-induced hearing loss in animals and has demonstrated safety and efficacy in studies for Meniere's disease and acute noise-induced hearing loss.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot use ototoxic medications (drugs that can harm the ear) within 60 days before the study, and you should avoid drugs that strongly affect liver enzymes within 30 days before the study.

Research Team

Jonathan Kil, MD

Principal Investigator

SOUND PHARMACEUTICALS, INC.

Eligibility Criteria

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL

1 week

Daily dosing

Calibrated Sound Challenge (CSC)

Participants are exposed to a calibrated sound challenge to induce a slight acute NIHL

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up hearing tests

1 week

Post-CSC hearing tests

Treatment Details

Interventions

• SPI-1005

Participant Groups

Group I: SPI-1005 400 mg Active Control 1 Intervention

400 mg SPI-1005, capsule, bid, po, x7d

Group II: SPI-1005 200 mg Active Control 1 Intervention

200 mg SPI-1005, capsule, bid, po, x7d

Group III: Placebo Placebo Group 1 Intervention

0 mg SPI-1005, capsule, bid, po, x7d

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials

14

Recruited

1,300+