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

Phase 1
Waitlist Available
Research Sponsored by Frequency Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Summary

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.

Eligible Conditions
  • Sensorineural Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUClast
CL/F
Cmax
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: FX-345 Cohort 2Experimental Treatment1 Intervention
Patients in the second cohort receiving FX-345 intratympanic injection
Group II: FX-345 Cohort 1Experimental Treatment1 Intervention
Patients in the first cohort receiving FX-345 intratympanic injection
Group III: Placebo Cohort 1Placebo Group1 Intervention
Patients in the first cohort receiving placebo intratympanic injection
Group IV: Placebo Cohort 2Placebo Group1 Intervention
Patients in the second cohort receiving placebo intratympanic injection

Find a Location

Who is running the clinical trial?

Frequency TherapeuticsLead Sponsor
6 Previous Clinical Trials
330 Total Patients Enrolled
Carl LeBel, PhDStudy DirectorFrequency Therapeutics
15 Previous Clinical Trials
1,743 Total Patients Enrolled
~2 spots leftby Dec 2025
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