Status:
COMPLETED
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Lead Sponsor:
Contineum Therapeutics
Conditions:
Sensorineural Hearing Loss
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04462198
Start Date
October 15 2020
End Date
June 17 2021
Last Update
April 1 2025
Active Locations (8)
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1
Breathe Clear Institute
Torrance, California, United States, 90503
2
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States, 33487
3
Advanced ENT & Allergy
New Albany, Indiana, United States, 47150
4
University of Kansas; Dept of Otolaryngology Head & Neck Surgery
Kansas City, Kansas, United States, 66160