Sensorineural Hearing Loss
Conditions
Keywords
Hearing Loss, Cochlear synaptopathy, Deafness, Speech-in-noise hearing difficulty
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 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.
Interventions
DRUGPIPE-505
Intratympanic injection
DRUGPlacebo
Intratympanic injection
Sponsors
Contineum Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The dose preparer and treatment administrator will be unmasked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Treatment-Emergent Adverse Events (TEAE) | From baseline to 3 months follow up | Number of participants with TEAEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PIPE-505 PIPE-505: Intratympanic injection | 21 |
| Placebo Diluent alone: Intratympanic injection | 7 |
| Total | 28 |
Baseline characteristics
| Characteristic | PIPE-505 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 7.93 | 62.2 years STANDARD_DEVIATION 8.85 | 58.9 years STANDARD_DEVIATION 11.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 27 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 27 Participants | 7 Participants |
| Region of Enrollment United States | 21 participants | 28 participants | 7 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 7 |
| other Total, other adverse events | 13 / 21 | 5 / 7 |
| serious Total, serious adverse events | 0 / 21 | 0 / 7 |
Outcome results
Primary
Safety: Treatment-Emergent Adverse Events (TEAE)
Number of participants with TEAEs
Time frame: From baseline to 3 months follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PIPE-505 | Safety: Treatment-Emergent Adverse Events (TEAE) | 13 Participants |
| Placebo | Safety: Treatment-Emergent Adverse Events (TEAE) | 5 Participants |