FX-322 in Sensorineural Hearing Loss

• ClinicalTrials.gov Identifier: NCT03616223
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: April 10, 2019
• Sponsor: Frequency Therapeutics
• Information provided by (Responsible Party): Frequency Therapeutics

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 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
• Actual Primary Completion Date: December 31, 2018
• Actual Study Completion Date: April 1, 2019

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

• Responsible Party: Frequency Therapeutics
• ClinicalTrials.gov Identifier: NCT03616223
• Other Study ID Numbers: FX-322-201
• First Posted: August 6, 2018
• Last Update Posted: April 10, 2019
• Last Verified: April 2019

• 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