NCT04120116

Brief Summary

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

September 30, 2019

Results QC Date

March 30, 2023

Last Update Submit

April 25, 2023

Conditions

Sensorineural Hearing LossNoise Induced Hearing LossSudden Sensorineural Hearing Loss

Keywords

Intratympanic AdministrationRestoration of Hearing Function

Outcome Measures

Primary Outcomes (6)

  • Word Recognition in Quiet

    Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists

    Baseline to Day 210

  • Words-in-Noise

    Mean absolute percent change in number of recognized words from CNC word lists

    Baseline to Day 210

  • Pure Tone Audiometry

    Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4kHZ frequencies

    Baseline to Day 210

  • Treatment-emergent Adverse Events (TEAEs)

    Number of patients with treatment-related adverse events assessed by CTCAE v5.0

    Baseline to Day 210

  • Otoscopy Abnormalities

    Number of treated ears with abnormalities of the external ear canal, tympanic membrane and middle ear at each specified time point

    Baseline and Days 8, 15, 21 60, 90,150, and 210

  • Tympanometry Abnormalities

    Number of treated ears with changes in middle ear compliance (mL), peak pressure (daPa), and/or ear canal volume (mL) from baseline

    Baseline and Days 15, 60, 90, 150, 210

Study Arms (4)

FX-322 Single Dose, Placebo Three Doses

EXPERIMENTAL

Four intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses.

Drug: FX-322 (One Dose)Drug: Placebo

FX-322 Two Doses, Placebo Two Doses

EXPERIMENTAL

Four intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses.

Drug: FX-322 (Two Doses)Drug: Placebo

FX-322 Four Doses

EXPERIMENTAL

Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses.

Drug: FX-322 (Four Doses)

Placebo Four Doses

PLACEBO COMPARATOR

Four intratympanic injections of a hydrogel formulation, Placebo Four Doses.

Drug: Placebo

Interventions

FX-322 (One Dose)DRUG

Patients will receive one dose of FX-322.

FX-322 Single Dose, Placebo Three Doses
FX-322 (Two Doses)DRUG

Patients will receive two doses of FX-322.

FX-322 Two Doses, Placebo Two Doses
FX-322 (Four Doses)DRUG

Patients will receive four doses of FX-322.

FX-322 Four Doses
PlaceboDRUG

Patients will receive Placebo.

FX-322 Single Dose, Placebo Three DosesFX-322 Two Doses, Placebo Two DosesPlacebo Four Doses

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years inclusive.
  • Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a single frequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).
  • Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
  • Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
  • Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.

You may not qualify if:

  • Previous participation in FX-322 clinical trial.
  • Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
  • 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 visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
  • Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  • Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
  • History of clinically significant vestibular symptoms at the discretion of the investigator.
  • History of clinically significant systemic autoimmune disease.
  • History of head or neck radiation treatment or exposure.
  • History of platinum-based chemotherapy treatment.
  • Exposure to another investigational drug within 28 days prior to injection of study drug.
  • Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
  • History of substance abuse within 2 years of the Screening Visit.
  • Positive test for drugs of abuse at screening.
  • Positive urine pregnancy test or breast-feeding.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Clinical Trial Site

Fresno, California, 93720, United States

Location

Clinical Trial Site

Torrance, California, 90503, United States

Location

Clinical Trial Site

Colorado Springs, Colorado, 80909, United States

Location

Clinical Trial Site

Boca Raton, Florida, 33487, United States

Location

Clinical Trial Site

Sarasota, Florida, 34239, United States

Location

Clinical Trial Site

Tampa, Florida, 33612, United States

Location

Clinical Trial Site

Louisville, Kentucky, 40207, United States

Location

Clinical Trial Site

Omaha, Nebraska, 68118, United States

Location

Clinical Trial Site

Amherst, New York, 14226, United States

Location

Clinical Trial Site

Matthews, North Carolina, 28105, United States

Location

Clinical Trial Site

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Trial Site

Orangeburg, South Carolina, 29118, United States

Location

Clinical Trial Site

Austin, Texas, 78705, United States

Location

Clinical Trial Site

San Antonio, Texas, 78240, United States

Location

Clinical Trial Site

San Antonio, Texas, 78258, United States

Location

Clinical Trial Site

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss, Noise-InducedHearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Clinical Trials
Organization
Frequency Therapeutics
clinicaltrialsinformation@frequencytx.com
781-315-4600

Study Officials

  • Carl LeBel, PhD

    Frequency Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 9, 2019

Study Start

October 4, 2019

Primary Completion

October 6, 2020

Study Completion

December 17, 2020

Last Updated

April 27, 2023

Results First Posted

April 27, 2023

Record last verified: 2023-04

Locations

US(16)