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
Verified date | June 2022 |
Source | Pipeline Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Pipeline Therapeutics, Inc. |
United States,
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 |
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