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

NCT04462198 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: PTI-505-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 8

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.

Conditions

Sensorineural Hearing Loss

Keywords

Hearing Loss; Cochlear synaptopathy; Deafness; Speech-in-noise hearing difficulty

Outcome Measures

Primary Outcomes (1)

• Safety: Treatment-Emergent Adverse Events (TEAE)

  Number of participants with TEAEs

  From baseline to 3 months follow up

Study Arms (2)

PIPE-505

EXPERIMENTAL

Drug: PIPE-505

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PIPE-505 DRUG

Intratympanic injection

PIPE-505

Placebo DRUG

Intratympanic injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contineum Therapeutics: lead

Study Sites (8)

Breathe Clear Institute

Torrance, California, 90503, United States

Location

ENT and Allergy Associates of Florida

Boca Raton, Florida, 33487, United States

Location

Advanced ENT & Allergy

New Albany, Indiana, 47150, United States

Location

University of Kansas; Dept of Otolaryngology Head & Neck Surgery

Kansas City, Kansas, 66160, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40220, United States

Location

Charlotte Eye Ear Nose Throat Associates

Charlotte, North Carolina, 28210, United States

Location

Piedmont Ear Nose Throat and Associates

Winston-Salem, North Carolina, 27103, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss; Hearing Loss, Hidden; Deafness

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephen Huhn, MD
• Organization: Pipeline Therapeutics, Inc.

SHuhn@pipeline-tx.com

858-333-5280

Study Officials

• Stephen Huhn, MD

  Chief Medical Officer, Pipeline Therapeutics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The dose preparer and treatment administrator will be unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 8, 2020
• Study Start: October 15, 2020
• Primary Completion: June 17, 2021
• Study Completion: June 17, 2021
• Last Updated: April 1, 2025
• Results First Posted: March 4, 2025

Record last verified: 2020-10

Locations

US (8)