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

Primary Purpose

Hearing Loss, Sensorineural

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FX-345
Placebo
Sponsored by
Frequency Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Hearing loss, Intratympanic Injection

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

FX-345 Cohort 1

Placebo Cohort 1

FX-345 Cohort 2

Placebo Cohort 2

Arm Description

Patients in the first cohort receiving FX-345 intratympanic injection

Patients in the first cohort receiving placebo intratympanic injection

Patients in the second cohort receiving FX-345 intratympanic injection

Patients in the second cohort receiving placebo intratympanic injection

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
Cmax
Maximum (peak) observed plasma drug concentration of FX04 and FX00 in cohort 1 participants
AUClast
Area under the concentration-time curve of FX04 and FX00 in cohort 1 participants
CL/F
Apparent total body clearance of FX04 and FX00 in cohort 1 participants
Vss
Apparent volume of distribution at steady state of FX04 and FX00 in cohort 1 participants
t1/2
Elimination half-life of FX04 and FX00 in cohort 1 participants
Tmax
Time to reach maximum (peak) plasma drug concentration of FX04 and FX00 in cohort 1 participants
Elimination rate constant
The rate at which FX04 and FX00 is removed from the human system in cohort 1 participants

Secondary Outcome Measures

Full Information

First Posted
December 13, 2022
Last Updated
April 25, 2023
Sponsor
Frequency Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05664100
Brief Title
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
April 12, 2023 (Actual)
Study Completion Date
April 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Frequency Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
Hearing loss, Intratympanic Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FX-345 Cohort 1
Arm Type
Experimental
Arm Description
Patients in the first cohort receiving FX-345 intratympanic injection
Arm Title
Placebo Cohort 1
Arm Type
Placebo Comparator
Arm Description
Patients in the first cohort receiving placebo intratympanic injection
Arm Title
FX-345 Cohort 2
Arm Type
Experimental
Arm Description
Patients in the second cohort receiving FX-345 intratympanic injection
Arm Title
Placebo Cohort 2
Arm Type
Placebo Comparator
Arm Description
Patients in the second cohort receiving placebo intratympanic injection
Intervention Type
Drug
Intervention Name(s)
FX-345
Intervention Description
Single intratympanic injection of FX-345
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intratympanic injection of placebo
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
Time Frame
Baseline Through Day 90
Title
Cmax
Description
Maximum (peak) observed plasma drug concentration of FX04 and FX00 in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Title
AUClast
Description
Area under the concentration-time curve of FX04 and FX00 in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Title
CL/F
Description
Apparent total body clearance of FX04 and FX00 in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Title
Vss
Description
Apparent volume of distribution at steady state of FX04 and FX00 in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Title
t1/2
Description
Elimination half-life of FX04 and FX00 in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Title
Tmax
Description
Time to reach maximum (peak) plasma drug concentration of FX04 and FX00 in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Title
Elimination rate constant
Description
The rate at which FX04 and FX00 is removed from the human system in cohort 1 participants
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Frequency Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Clinical Trial Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States

12. IPD Sharing Statement

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

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