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Small Molecule

FX-322 High Dose for Sensorineural Hearing Loss

Phase 1 & 2
Waitlist Available
Led By George Atiee, MD
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, 8, 24 hours post-dose

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.

Eligible Conditions
  • Sensorineural Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data points taken pre-dose and 0.5, 1, 2, 4, 8, 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, 8, 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
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
Secondary study objectives
AUClast
CL/F
Cmax
+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 23 Patients • NCT03616223
71%
Ear Discomfort
14%
Viral Upper Respiratory Tract Infection
14%
Ear Pain
14%
Oropharyngeal Pain
14%
Ear Pruritus
14%
Toothache
14%
Dizziness
14%
Muscle Spasms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo-Low Dose
Placebo-High Dose
Pooled Placebo
FX-322 Low Dose
FX-322 High Dose

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: FX-322 Low DoseExperimental Treatment1 Intervention
Cohort of 8. Single intratympanic injection
Group II: FX-322 High DoseExperimental Treatment1 Intervention
Cohort of 8. Single intratympanic injection
Group III: Placebo-Low DosePlacebo Group1 Intervention
Cohort of 4. Single intratympanic injection
Group IV: Placebo-High DosePlacebo Group1 Intervention
Cohort of 4. Single intratympanic injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FX-322
2020
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Frequency TherapeuticsLead Sponsor
6 Previous Clinical Trials
313 Total Patients Enrolled
George Atiee, MDPrincipal InvestigatorWorldwide Clinical Trials
5 Previous Clinical Trials
449 Total Patients Enrolled
~3 spots leftby Oct 2025
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