This study is now CLOSED

Pipeline Therapeutics: Phase I/II

a Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

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

Inclusion Criteria:

1. Subject’s primary language is English.
2. Male or female between 18 and 75 years of age, inclusive, at randomization.
3. Diagnosis of bilateral sensorineural hearing loss (SNHL).
4. Normal tympanogram bilaterally (as defined in protocol) at Screening.
5. 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.
6. 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:

1. 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.
2. Presence of a genetic, syndromal or developmental auditory disorder or of an autoimmune or serious neurological disorder that could contribute to auditory loss.
3. Evidence of current conductive hearing loss, mixed hearing loss or otosclerosis.
4. History of auditory loss related to exposure to known ototoxic drugs; any prior exposure to platinum-based medications.
5. Otological disorders that would preclude safe tympanic injection.
6. Presence of a cochlear implant.
7. Evidence of disturbing tinnitus as defined by the protocol.
8. Intratympanic injection within 6 months of randomization.
9. 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.
10. History of prior malignancy, with the exception of carcinoma in situ of the uterine cervix and treated localized basal cell or squamous cell carcinoma of the skin.

For more information please contact our research team at Research@AdvancedENTandAllergy.com or call 502.995.5525 and ask for the Research Department.

This study is now CLOSED