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

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Brief Title

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

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

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 Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety: Treatment-Emergent Adverse Events (TEAE)

Secondary Outcome

 Pharmacokinetics: Area under the curve (AUC)

Condition

Sensorineural Hearing Loss

Intervention

PIPE-505

Study Arms / Comparison Groups

 PIPE-505
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

August 2020

Completion Date

July 2021

Primary Completion Date

November 2020

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 bilaterally (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 ototoxic drugs; any prior
             exposure to platinum-based medications.

          -  Otological disorders that would preclude safe tympanic injection.

          -  Presence of a cochlear implant.

          -  Evidence of disturbing tinnitus as defined by the protocol.

          -  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 prior malignancy, with the exception of carcinoma in situ of the uterine
             cervix and treated localized basal cell or squamous cell carcinoma of the skin.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Stephen Huhn, MD, 858-254-8480, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04462198

Organization ID

PTI-505-101


Responsible Party

Sponsor

Study Sponsor

Pipeline Therapeutics, Inc.


Study Sponsor

Stephen Huhn, MD, Study Director, Chief Medical Officer, Pipeline Therapeutics, Inc


Verification Date

September 2019