Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

NCT ID: NCT04462198

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-06-17

Brief Summary

This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.

Detailed Description

This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other audiological tests.

Conditions

Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PIPE-505

Group Type: EXPERIMENTAL

PIPE-505

Intervention Type: DRUG

Intratympanic injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intratympanic injection

Interventions

PIPE-505

Intratympanic injection

Intervention Type: DRUG

Placebo

Intratympanic injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject's primary language is English.
• Male or female between 18 and 75 years of age, inclusive, at randomization.
• Diagnosis of bilateral sensorineural hearing loss (SNHL).
• Normal tympanogram in the ear intended for injection (as defined in protocol) at Screening.
• Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method during and for 3 months after study drug administration.
• The subject is in general good medical health with no clinically significant or relevant abnormalities, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.

Exclusion Criteria

• History of chronic otitis externa or media, other chronic middle ear disorders, barotrauma, Meniere's disease, endolymphatic hydrops, perilymph fistula, herpes zoster oticus or other infectious etiology of hearing loss.
• Presence of a genetic, syndromal or developmental auditory disorder or of an autoimmune or serious neurological disorder that could contribute to auditory loss.
• Evidence of current conductive hearing loss, mixed hearing loss or otosclerosis.
• History of auditory loss related to exposure to known high-dose ototoxic drugs; any prior exposure to platinum-based medications.
• Otological disorders that would preclude safe tympanic injection.
• Presence of a cochlear implant.
• Evidence of bothersome tinnitus as determined by the Investigator.
• Intratympanic injection within 6 months of randomization.
• Use of an investigational product or intervention other than a non-interventional registry study (including vaccine studies) within the greater of 30 days or 5 half-lives (if known) prior to Screening or expected during the study.
• History of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, as determined by the Investigator. Note, central nervous system neoplasms or head and neck cancer are excluded from eligibility regardless of treatment status.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Contineum Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Huhn, MD

Role: STUDY_DIRECTOR

Chief Medical Officer, Pipeline Therapeutics, Inc

Locations

Breathe Clear Institute

Torrance, California, United States

ENT and Allergy Associates of Florida

Boca Raton, Florida, United States

Advanced ENT & Allergy

New Albany, Indiana, United States

University of Kansas; Dept of Otolaryngology Head & Neck Surgery

Kansas City, Kansas, United States

Advanced ENT & Allergy

Louisville, Kentucky, United States

Charlotte Eye Ear Nose Throat Associates

Charlotte, North Carolina, United States

Piedmont Ear Nose Throat and Associates

Winston-Salem, North Carolina, United States

Chrysalis Clinical Research

St. George, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PTI-505-101

Identifier Type: -

Identifier Source: org_study_id