Clinical trial: Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss (NCT04462198)

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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction