A Phase 1b, Prospective, Randomized, Double-Blind, Placebo- Controlled, Single-Dose, Multicenter, Safety Study of FX-322 Administered by Intratympanic Injection in Adults With Severe Sensorineural Hearing Loss
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Columbia-Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
详细描述
This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss.
Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
- •Adult aged 18-65 years inclusive.
- •Documented medical history consistent with acquired (non-genetic) severe sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
- •A pure tone average of 71-90 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at Screening in the ear to be injected.
- •Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
排除标准
- •Subject has previously participated in a FX-322 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 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 3 months of the screening visit.
- •History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not.
- •History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
- •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).
- •Females of childbearing potential (those who are not surgically sterilized or post- menopausal) may not participate in the study if any of the following conditions exist:
- •Pregnant or intend to become pregnant
- •Nursing (lactating)
- •Does not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal- oral, implantable, transdermal or injectable contraceptives; mechanical- spermicide in conjunction with a barrier such as a condom or diaphragm, IUD, or surgical sterilization of a partner.
- •NOTE: all female subjects of childbearing potential must consent to a urine pregnancy test as described in the Schedule of Assessments. Male subjects should use condoms with spermicide during the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
- •Any known factor, condition, or disease that, in the view of the Investigator, might interfere with treatment compliance, study conduct or interpretation of the results.
研究组 & 干预措施
FX-322
FX-322, 1 dose (N=24)
干预措施: FX-322 (Drug)
Placebo
Placebo, 1 dose (n=6)
干预措施: Placebo (Other)
结局指标
主要结局
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 3 months
Risk assessment through a series of simple, plain-language questions
Local Safety: The number of patients with abnormal changes from baseline in tympanometry
时间窗: 3 months
Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.
Systemic Safety: Number of patients with treatment-related adverse events
时间窗: 3 months
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations
时间窗: 3 months
Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.
次要结局
- Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR)(3 months)
- Audiologic Response: Speech Intelligibility - Bamford-Kowal-Bench Speech in Noise (BKB-SIN)(3 months)
- Standard Pure Tone Audiometry(3 months)
- Extended High Frequency Pure Tone Audiometry(3 months)
- Tinnitus Assessment(2 months)