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

Frequency Therapeutics1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2022年12月15日最近更新: 2023年4月27日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 6
试验地点: 1
主要终点: Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 67 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

FX-345 Cohort 1

Experimental

Patients in the first cohort receiving FX-345 intratympanic injection

干预措施: FX-345 (Drug)

Placebo Cohort 1

Placebo Comparator

Patients in the first cohort receiving placebo intratympanic injection

干预措施: Placebo (Drug)

FX-345 Cohort 2

Experimental

Patients in the second cohort receiving FX-345 intratympanic injection

干预措施: FX-345 (Drug)

Placebo Cohort 2

Placebo Comparator

Patients in the second cohort receiving placebo intratympanic injection

干预措施: Placebo (Drug)

结局指标