FX-322 in Adults With Acquired Sensorineural Hearing Loss
Recruiting at 26 trial locations
CT
Overseen ByClinical Trials Information Desk
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Frequency Therapeutics
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial tests FX-322, a drug injected into the ear, in adults aged 18 to 65 with acquired hearing loss. The drug aims to improve hearing by repairing or regenerating cells in the ear. FX-322, a combination of CHIR99021 and valproic acid, has been shown to regenerate mammalian cochlear hair cells.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Research Team
CL
Carl LeBel, PhD
Principal Investigator
Frequency Therapeutics
Eligibility Criteria
Inclusion Criteria
The subject has read and agreed to the terms of the Informed Consent Form, answering any questions they may have about the study
Female subjects must either not be able to have children or must use two methods of contraception, like hormonal contraception and a condom, or they must remain abstinent
The subject seems to be able to communicate effectively with the researcher and is willing to comply with all the study procedures.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single intratympanic injection of FX-322 or placebo
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Multiple visits (in-person) through Day 90
Treatment Details
Interventions
- FX-322
- Placebo
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: FX-322Active Control1 Intervention
FX-322, 1 dose
Group II: PlaceboPlacebo Group1 Intervention
Placebo, 1 dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Frequency Therapeutics
Lead Sponsor
Trials
7
Recruited
340+
Findings from Research
The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.
Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels.Piacentino, D., Ogirala, A., Lew, R., et al.[2023]
In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.
Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies.Rosenzweig, P., Brohier, S., Zipfel, A.[2023]
References
A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. [2023]
The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]
Efficacy, Tolerability, and Safety of DFN-15 (Celecoxib Oral Solution, 25 mg/mL) in the Acute Treatment of Episodic Migraine: A Randomized, Double-Blind, Placebo-Controlled Study. [2021]
ADVERPred-Web Service for Prediction of Adverse Effects of Drugs. [2018]
Dataset for amiodarone adverse events compared to placebo using data from randomized controlled trials. [2020]
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