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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462198
Recruitment Status : Completed
First Posted : July 8, 2020
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Pipeline Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 8, 2020
Last Update Posted Date June 10, 2022
Actual Study Start Date  ICMJE October 15, 2020
Actual Primary Completion Date June 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2020)
Safety: Treatment-Emergent Adverse Events (TEAE) [ Time Frame: From baseline to 3 months follow up ]
Number of participants with TEAEs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2020)
  • Pharmacokinetics: Area under the curve (AUC) [ Time Frame: From baseline to 3 months follow up ]
  • Pharmacokinetics: t1/2 (half life) [ Time Frame: From baseline to 3 months follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 4, 2020)
  • 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
  • Exploratory: Audiogram tests [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Hearing sensitivity and thresholds with a quiet background
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Sensorineural Hearing Loss
Intervention  ICMJE
  • Drug: PIPE-505
    Intratympanic injection
  • Drug: Placebo
    Intratympanic injection
Study Arms  ICMJE
  • Experimental: PIPE-505
    Intervention: Drug: PIPE-505
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2021)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2020)
24
Actual Study Completion Date  ICMJE June 17, 2021
Actual Primary Completion Date June 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04462198
Other Study ID Numbers  ICMJE PTI-505-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pipeline Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pipeline Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen Huhn, MD Chief Medical Officer, Pipeline Therapeutics, Inc
PRS Account Pipeline Therapeutics, Inc.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP