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Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

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ClinicalTrials.gov Identifier: NCT04462198
Recruitment Status : Completed
First Posted : July 8, 2020
Last Update Posted : June 10, 2022
Information provided by (Responsible Party):
Pipeline Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Drug: PIPE-505 Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The dose preparer and treatment administrator will be unmasked.
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2020
Actual Primary Completion Date : June 17, 2021
Actual Study Completion Date : June 17, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PIPE-505 Drug: PIPE-505
Intratympanic injection

Placebo Comparator: Placebo Drug: Placebo
Intratympanic injection

Primary Outcome Measures :
  1. Safety: Treatment-Emergent Adverse Events (TEAE) [ Time Frame: From baseline to 3 months follow up ]
    Number of participants with TEAEs

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the curve (AUC) [ Time Frame: From baseline to 3 months follow up ]
  2. Pharmacokinetics: t1/2 (half life) [ Time Frame: From baseline to 3 months follow up ]

Other Outcome Measures:
  1. Exploratory: Speech-in-noise assessments [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Hearing performance in the setting of background noise

  2. Exploratory: Audiogram tests [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Hearing sensitivity and thresholds with a quiet background

  3. Exploratory: Auditory brainstem potential testing [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Electrophysiological assessment of auditory nerve and brainstem responses to auditory signals

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462198

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United States, California
Breathe Clear Institute
Torrance, California, United States, 90503
United States, Florida
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States, 33487
United States, Indiana
Advanced ENT & Allergy
New Albany, Indiana, United States, 47150
United States, Kansas
University of Kansas; Dept of Otolaryngology Head & Neck Surgery
Kansas City, Kansas, United States, 66160
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40220
United States, North Carolina
Charlotte Eye Ear Nose Throat Associates
Charlotte, North Carolina, United States, 28210
Piedmont Ear Nose Throat and Associates
Winston-Salem, North Carolina, United States, 27103
United States, Utah
Chrysalis Clinical Research
Saint George, Utah, United States, 84790
Sponsors and Collaborators
Pipeline Therapeutics, Inc.
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Study Director: Stephen Huhn, MD Chief Medical Officer, Pipeline Therapeutics, Inc
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Responsible Party: Pipeline Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04462198    
Other Study ID Numbers: PTI-505-101
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pipeline Therapeutics, Inc.:
Hearing Loss
Cochlear synaptopathy
Speech-in-noise hearing difficulty
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases