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

Sensorineural Hearing Loss Clinical Trial

Official title:

A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Unilateral Intratympanic PIPE-505 in Subjects With Sensorineural Hearing Loss Associated With Speech-in-Noise Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462198
• Other study ID #: PTI-505-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 15, 2020
• Est. completion date: June 17, 2021

Study information

• Verified date: June 2022
• Source: Pipeline Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 17, 2021
• Est. primary completion date: June 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Drug:
• PIPE-505
Intratympanic injection
• Placebo
Intratympanic injection

Locations

Country	Name	City	State
United States	ENT and Allergy Associates of Florida	Boca Raton	Florida
United States	Charlotte Eye Ear Nose Throat Associates	Charlotte	North Carolina
United States	University of Kansas; Dept of Otolaryngology Head & Neck Surgery	Kansas City	Kansas
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	Advanced ENT & Allergy	New Albany	Indiana
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Breathe Clear Institute	Torrance	California
United States	Piedmont Ear Nose Throat and Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pipeline Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Speech-in-noise assessments	Hearing performance in the setting of background noise	1 month, 2 months, and 3 months after drug administration
Other	Exploratory: Audiogram tests	Hearing sensitivity and thresholds with a quiet background	1 month, 2 months, and 3 months after drug administration
Other	Exploratory: Auditory brainstem potential testing	Electrophysiological assessment of auditory nerve and brainstem responses to auditory signals	1 month, 2 months, and 3 months after drug administration
Primary	Safety: Treatment-Emergent Adverse Events (TEAE)	Number of participants with TEAEs	From baseline to 3 months follow up
Secondary	Pharmacokinetics: Area under the curve (AUC)		From baseline to 3 months follow up
Secondary	Pharmacokinetics: t1/2 (half life)		From baseline to 3 months follow up