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

NCT05664100 | Terminated Phase 1 FDA Drug

• 1 other identifier: FX-345-101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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.

Conditions

Hearing Loss, Sensorineural

Keywords

Hearing loss; Intratympanic Injection

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)

  Baseline Through Day 90

• Cmax

  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

  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

  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

  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

  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 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

  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

Study Arms (4)

FX-345 Cohort 1

EXPERIMENTAL

Patients in the first cohort receiving FX-345 intratympanic injection

Drug: FX-345

Placebo Cohort 1

PLACEBO COMPARATOR

Patients in the first cohort receiving placebo intratympanic injection

Drug: Placebo

FX-345 Cohort 2

EXPERIMENTAL

Patients in the second cohort receiving FX-345 intratympanic injection

Drug: FX-345

Placebo Cohort 2

PLACEBO COMPARATOR

Patients in the second cohort receiving placebo intratympanic injection

Drug: Placebo

Interventions

FX-345 DRUG

Single intratympanic injection of FX-345

FX-345 Cohort 1; FX-345 Cohort 2

Placebo DRUG

Single intratympanic injection of placebo

Placebo Cohort 1; Placebo Cohort 2

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frequency Therapeutics: lead

Study Sites (4)

Clinical Trial Site

Sarasota, Florida, 34239, United States

Location

Clinical Trial Site

Spartanburg, South Carolina, 29303, United States

Location

Clinical Trial Site

San Antonio, Texas, 78240, United States

Location

Clinical Trial Site

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl LeBel, PhD

  Frequency Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 23, 2022
• Study Start: December 15, 2022
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (4)