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Trial record 1 of 2 for:    FX-322
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FX-322 in Sensorineural Hearing Loss

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ClinicalTrials.gov Identifier: NCT03616223
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Brief Summary:
This is a phase 1/2 single dose study of FX-322 compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Drug: FX-322 Drug: Placebo Phase 1 Phase 2

Detailed Description:
Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The study will assess the safety of FX-322 given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. Safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood PK profile of FX-322 will also be determined.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Randomized, Double-blind, Placebo-controlled, Single-dose Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FX-322 Low Dose
Single intratympanic injection of a hydrogel formulation
Drug: FX-322
Cohort of 8 subjects

Experimental: FX-322 High Dose
Single intratympanic injection of a hydrogel formulation
Drug: FX-322
Cohort of 8 subjects

Placebo Comparator: Placebo
Single intratympanic injection of a hydrogel formulation
Drug: Placebo
2 Cohorts of 4 subjects each




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Time-concentration profile of FX-322 in plasma [ Time Frame: Baseline, Day 1, Day 2 ]
    Blood samples to be collected within the first 24 hours of dosing to measure drug concentration in the circulation.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult aged 18-65 years.
  2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months.
  3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
  4. Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.

Exclusion Criteria:

  1. 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 either ear. This includes a current tympanostomy tubes.
  2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
  3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
  4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  5. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
  6. History of clinically significant vestibular symptoms at the discretion of the investigator.
  7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  8. History of head or neck radiation treatment or exposure.
  9. History of substance abuse within 2 years of the Screening Visit.
  10. Positive urine pregnancy test or breast-feeding.
  11. 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 such as psychiatric disease or suicidal tendencies.

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): NCT03616223


Locations
United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Frequency Therapeutics
Investigators
Principal Investigator: George Atiee, MD Worldwide Clinical Trials

Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT03616223     History of Changes
Other Study ID Numbers: FX-322-201
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frequency Therapeutics:
Intratympanic Administration
Hearing Restoration

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms