FX-322 in Sensorineural Hearing Loss

NCT03616223 | Completed Phase 1 Results FDA Drug

• 1 other identifier: FX-322-201
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sensorineural Hearing Loss

Keywords

Intratympanic Administration; Hearing Restoration

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)

  Treatment-emergent adverse events (TEAE) were defined as any untoward medical occurrence in a subject administered study drug that does not necessarily have a causal relationship with the treatment and were collected from the time of first dose through end of study (day 90). In particular, audiometric and otoscopic TEAEs were recorded per the American Speech-Language-Hearing Association (ASHA) guidelines.

  Baseline through Day 90

Secondary Outcomes (5)

• Cmax

  Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose

• Tmax

  Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose

• AUClast

  Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose

• t1/2

  Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose

• CL/F

  Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose

Study Arms (4)

FX-322 Low Dose

EXPERIMENTAL

Cohort of 8. Single intratympanic injection

Drug: FX-322

FX-322 High Dose

EXPERIMENTAL

Cohort of 8. Single intratympanic injection

Drug: FX-322

Placebo-Low Dose

PLACEBO COMPARATOR

Cohort of 4. Single intratympanic injection

Drug: Placebo

Placebo-High Dose

PLACEBO COMPARATOR

Cohort of 4. Single intratympanic injection

Drug: Placebo

Interventions

FX-322 DRUG

Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate

FX-322 High Dose; FX-322 Low Dose

Placebo DRUG

Intratympanic injection

Placebo-High Dose; Placebo-Low Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 18-65 years.
• Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for \>6 months.
• 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).
• 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.

You may not qualify if:

• 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.
• Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
• A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
• 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 6 months of the screening visit.
• History of clinically significant vestibular symptoms at the discretion of the investigator.
• History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
• History of head or neck radiation treatment or exposure.
• History of substance abuse within 2 years of the Screening Visit.
• Positive urine pregnancy test or breast-feeding.
• 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.

Sponsors & Collaborators

• Frequency Therapeutics: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Links

• Journal article

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carl LeBel, PhD, CDO
• Organization: Frequency Therapeutics

clinicaltrialsinformation@frequencytx.com

781-315-4600

Study Officials

• George Atiee, MD

  Worldwide Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 6, 2018
• Study Start: July 3, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Locations

US (1)