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

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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The study will start with a small group to check safety and later involve a larger group to confirm these findings.

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.

Research Team

Carl LeBel, PhD

Principal Investigator

Frequency Therapeutics

Eligibility Criteria

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

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

Treatment Details

Interventions

• FX-345
• Placebo

Participant Groups

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+