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FX-345 Cohort 1 for 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
Awards & highlights

Study Summary

This trial will evaluate the safety of an injection to improve hearing loss in adults. Primary objectives are to assess safety & how it works in the body.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUClast
CL/F
Cmax
+5 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study permit participants aged seventy and older?

"According to the study's selection criteria, only individuals aged 18 or above and below 67 can be considered for this trial."

Answered by AI

Has the FDA granted approval for FX-345 Cohort 1?

"FX-345 Cohort 1's safety is ranked with a score of 1 due to the limited clinical data that has been collected in its Phase 1 trial assessing efficacy and security."

Answered by AI

How many volunteers have been recruited to participate in this research?

"Affirmative. The clinical trial, initially advertised on December 1st 2022, is currently looking for volunteers to take part. Three medical centres need to recruit 36 patients in total."

Answered by AI

Are there still positions available to those interested in participating in this research?

"Visible on clinicaltrials.gov, this study is actively in search of volunteers. It was initially published on December 1st 2022 and the data was most recently updated on December 21th 2022."

Answered by AI

To what demographic is participation in this trial available?

"This clinical trial will accept applicants aged between 18 and 67 who are suffering from hearing loss and cochlear damage. A total of 36 participants can join this study."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
California

Why did patients apply to this trial?

I tried 3 other drugs that didn't work now I hope this clinical trial will help address my medical condition.
PatientReceived 2+ prior treatments
I have tried everything possible to find out about what caused my hearing loss , I run MRI scan twice, done everything, for more than 30 years I have been suffering from loud screeching sound in my right ear, and my left ear on its way to lose hearing, those sounds in my ear drive me crazy and I lost the pleasure of quietness , I wish if I can find an end for that continuous sounds or my life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
2022. "First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664100.
~3 spots leftby Apr 2025
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