FX-322 in Adults With Severe Sensorineural Hearing Loss

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    30
  • sponsor
    Frequency Therapeutics
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Updated on 28 January 2021
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Summary

This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.

Description

This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss.

Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection.

Details
Condition Sudden hearing loss, Sensorineural hearing loss, Hearing Loss, Acoustic Trauma, Auditory Loss and Deafness, Hearing Impairment, noise-induced hearing loss
Treatment Placebo, FX-322
Clinical Study IdentifierNCT04629664
SponsorFrequency Therapeutics
Last Modified on28 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Sudden hearing loss or noise-induced hearing loss or Acoustic Trauma or Sensorineural hearing loss or Hearing Loss or Hearing Impairment or Auditory L...?
Do you have any of these conditions: Auditory Loss and Deafness or Sensorineural hearing loss or noise-induced hearing loss or Sudden hearing loss or Hearing Impairment or Hearing Loss or...?
Do you have any of these conditions: Auditory Loss and Deafness or Sudden hearing loss or Sensorineural hearing loss or Hearing Loss or Acoustic Trauma or Hearing Impairment or noise-indu...?
Do you have any of these conditions: Auditory Loss and Deafness or Acoustic Trauma or noise-induced hearing loss or Hearing Loss or Sensorineural hearing loss or Hearing Impairment or Sud...?
Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure
Adult aged 18-65 years inclusive
Documented medical history consistent with severe sensorineural hearing loss (documented audiogram at least 6 months prior to screening required)
A pure tone average of 71-90 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at Screening in the ear to be injected
Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures

Exclusion Criteria

Subject has previously participated in a FX-322 clinical trial
Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube
Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted)
Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected
Subject has had an intratympanic injection in either ear within 3 months of the screening visit
History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not
History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis)
Exposure to another investigational drug within 28 days prior to injection of study drug
Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature)
Females of childbearing potential (those who are not surgically sterilized or postmenopausal) may not participate in the study if any of the following conditions exist
Pregnant or intend to become pregnant
Nursing (lactating)
Does not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal- oral, implantable, transdermal or injectable contraceptives; mechanical- spermicide in conjunction with a barrier such as a condom or diaphragm, IUD, or surgical sterilization of a partner
NOTE: all female subjects of childbearing potential must consent to a urine
pregnancy test as described in the Schedule of Assessments. Male subjects
should use condoms with spermicide during the study or remain abstinent
Subjects should not donate sperm or ova during the study period
\. Any known factor, condition, or disease that, in the view of the
Investigator, might interfere with treatment compliance, study conduct or
interpretation of the results
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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