FX-345 for Hearing Loss

No longer recruiting at 2 trial locations

Overseen By Frequency Therapeutics Clinical Trials Information Desk

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Frequency Therapeutics

Must not be taking: Steroids, others

Disqualifiers: Tympanic disorders, Conductive hearing loss, Meniere's disease, Traumatic brain injury, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called FX-345 for adults with sensorineural hearing loss, a common type of hearing loss caused by damage in the inner ear or nerve pathways. Participants will receive either a single injection of FX-345 or a placebo (a non-active treatment) to observe the body's response. The goal is to confirm that FX-345 is safe for further testing. Adults with diagnosed and documented sensorineural hearing loss may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had an intratympanic injection, steroid treatment, or sudden hearing loss within the last 3 months, you may not be eligible to participate.

Is there any evidence suggesting that FX-345 is likely to be safe for humans?

Research has shown that injections into the ear, such as those used for FX-345, are generally safe and well-tolerated. Ear, nose, and throat doctors commonly perform these injections. Although specific safety information for FX-345 is not widely available yet, its testing in an early phase trial indicates it is considered safe enough for initial human trials. This trial aims to determine the safety of FX-345 when injected into the ear for individuals with hearing loss. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FX-345 is unique because it offers a new way to potentially treat sensorineural hearing loss using an intratympanic injection, which directly delivers the drug to the middle ear. Unlike many current treatments, which often involve hearing aids or cochlear implants, FX-345 targets the condition at a cellular level. This approach aims to regenerate or protect the hair cells in the ear that are crucial for hearing, offering hope for more lasting improvements. Researchers are excited about FX-345 because it represents a shift from simply managing symptoms to addressing the underlying cause of hearing loss.

What evidence suggests that FX-345 might be an effective treatment for sensorineural hearing loss?

Research shows that FX-345 is a new treatment under testing for sensorineural hearing loss, a common type caused by damage to the inner ear or nerve pathways. In this trial, participants will receive either FX-345 or a placebo, both given as intratympanic injections. Although data on FX-345's effectiveness in people is limited, the treatment involves direct injection into the ear. This method already delivers steroids to some patients to improve hearing. Studies have found that injecting drugs directly into the ear can successfully reach the necessary areas, potentially improving hearing. FX-345 aims to restore hearing by addressing the root causes of hearing loss similarly. As research progresses, more information will emerge about its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Carl LeBel, PhD

Principal Investigator

Frequency Therapeutics

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a medical history of hearing loss that developed in adulthood.

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.

Exclusion Criteria

You have a current or past history of serious ear problems or surgery in the ear being treated.

You have a history of brain injury, Meniere's disease, or genetic hearing loss.

You have taken another experimental drug less than a month before the screening visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intratympanic injection of FX-345 or placebo

1 day

1 visit (in-person)

Safety Review

Sponsor conducts an unblinded safety review after Cohort 1

2 weeks

Follow-up

Participants are monitored for safety and pharmacokinetic profile post-treatment

4 weeks

Multiple visits for data collection

What Are the Treatments Tested in This Trial?

Interventions

• FX-345
• Placebo

How Is the Trial Designed?

Group I: FX-345 Cohort 2 Experimental Treatment 1 Intervention

Patients in the second cohort receiving FX-345 intratympanic injection

Group II: FX-345 Cohort 1 Experimental Treatment 1 Intervention

Patients in the first cohort receiving FX-345 intratympanic injection

Group III: Placebo Cohort 1 Placebo Group 1 Intervention

Patients in the first cohort receiving placebo intratympanic injection

Group IV: Placebo Cohort 2 Placebo Group 1 Intervention

Patients in the second cohort receiving placebo intratympanic injection

Who Is Running the Clinical Trial?

Frequency Therapeutics

Lead Sponsor

Trials

7

Recruited

340+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05664100

First in Human Safety Study of FX-345 in Adults With ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8712747/

Association Between the Number of Intratympanic Steroid ... This study investigated the potential association between the number of IT steroid injections and hearing recovery to determine the optimal number in sudden ...

3. biospace.com biospace.com/frequency-therapeutics-announces-first-patient-dosed-in-phase-1b-study-of-fx-345-the-company-s-second-therapeutic-candidate-for-sensorineural-hearing-loss

Frequency Therapeutics Announces First Patient Dosed in ... The Phase 1b trial, FX-345-101, is a prospective, randomized, single-blind, placebo-controlled, multicenter study to evaluate the safety of FX- ...

4. withpower.com withpower.com/trial/phase-1-hearing-loss-11-2022-57777

First in Human Safety Study of FX-345 in Adults With ... This trial is testing FX-345, a new drug, to see if it is safe for adults with hearing loss. The drug is given as a single injection into the ear.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5154844/

Hearing changes after intratympanically applied steroids ... For primary intratympanic or combined therapy of ISSHL there was no dependence of change in hearing threshold on the drug concentration used (figure 3a, 3b), ...

6. synapse.patsnap.com synapse.patsnap.com/drug/de1add16553f4a3cbd30631d0e9902f4

FX-345 - Drug Targets, Indications, Patents A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single ...

7. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/abs/10.1002/ohn.656

Intratympanic Gels for Inner Ear Disorders: A Scoping Review ... Objective Intratympanic injections are a safe, well tolerated procedure routinely performed by ENT's specialists. Intratympanic injections ...

8. hearinghealthmatters.org hearinghealthmatters.org/hearing-news-watch/2022/frequency-therapeutics-first-patient-fx-345/

Frequency Therapeutics Announces First Patient Dosed in ... The Phase 1b trial, FX-345-101, is a prospective, randomized, single-blind, placebo-controlled, multicenter study to evaluate the safety of FX- ...