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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • 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 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

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
Intervention / Treatment
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

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

Frequency Therapeutics

Investigators

  • 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)

December 15, 2022

Primary Completion (Actual)

April 12, 2023

Study Completion (Actual)

April 12, 2023

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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