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

April 25, 2023 updated by: Frequency Therapeutics

A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Clinical Trial Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Clinical Trial Site
    • Texas
      • San Antonio, Texas, United States, 78258
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78240
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult aged 18-67 years (inclusive)
  • Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
  • 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.
  • Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception

Exclusion Criteria:

  • Randomization in a FX-322 (laduviglusib and sodium valproate) clinical trial
  • Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
  • Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
  • Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  • Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
  • Evidence of or previous diagnosis of traumatic brain injury, Meniere's disease, or genetic hearing loss
  • History of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms
  • Exposure to another investigational drug within 28 days prior to screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FX-345 Cohort 1
Patients in the first cohort receiving FX-345 intratympanic injection
Drug: FX-345
Single intratympanic injection of FX-345
Placebo Comparator: Placebo Cohort 1
Patients in the first cohort receiving placebo intratympanic injection
Drug: Placebo
Single intratympanic injection of placebo
Experimental: FX-345 Cohort 2
Patients in the second cohort receiving FX-345 intratympanic injection
Drug: FX-345
Single intratympanic injection of FX-345
Placebo Comparator: Placebo Cohort 2
Patients in the second cohort receiving placebo intratympanic injection
Drug: Placebo
Single intratympanic injection of placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
Time Frame: Baseline Through Day 90
Baseline Through Day 90
Cmax
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Maximum (peak) observed plasma drug concentration of FX04 and FX00 in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
AUClast
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Area under the concentration-time curve of FX04 and FX00 in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
CL/F
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Apparent total body clearance of FX04 and FX00 in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Vss
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Apparent volume of distribution at steady state of FX04 and FX00 in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
t1/2
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Elimination half-life of FX04 and FX00 in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Tmax
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Time to reach maximum (peak) plasma drug concentration of FX04 and FX00 in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Elimination rate constant
Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
The rate at which FX04 and FX00 is removed from the human system in cohort 1 participants
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frequency Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Carl LeBel, PhD, Frequency Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FX-345-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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