TerminatedPhase 1

First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

Stopped: Business reasons

United States6 participantsStarted 2022-12-15

Plain-language summary

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

Who can participate

Age range

18 Years – 67 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult aged 18-67 years (inclusive) * Documented medical history consistent with acquired, adult onset, sensorineural hearing loss * At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected * Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test. * Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception Exclusion Criteria: * Randomization in a FX-322 (laduviglusib and sodium valproate) 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, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment. * Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected. * Within 3 months of screening visit any of the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline Through Day 90

Cmax

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

AUClast

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

CL/F

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Vss

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

t1/2

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Tmax

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Trial details

NCT IDNCT05664100

SponsorFrequency Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-12

View on ClinicalTrials.gov More Hearing Loss, Sensorineural trials

Plain-language summary

Who can participate

Age range

18 Years – 67 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline Through Day 90

Cmax

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

AUClast

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

CL/F

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Vss

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

t1/2

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Tmax

Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose