A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Otoscopic Examinations (Safety)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has audiometrically-defined normal hearing or up to moderately severe hearing impairment.
- •Subject has self-reported difficulty hearing in noisy environments for at least 6 months prior to Screening.
- •Subject exhibited a speech-in-noise hearing deficit in at least one ear.
排除标准
- •Subject is pregnant or lactating.
- •Subject has the following hearing disorders or any other hearing disorders that may impact the efficacy assessments or safety of the subject in the opinion of the Investigator: Meniere's disease, congenital hearing loss, or genetic sensorineural hearing loss.
- •Subject has a cochlear implant or consistently uses a hearing aid.
- •Subject has worked at least 5 years as a professional musician or has had at least 15 years of formal musical training.
- •Subject self-reports bothersome, subjective tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
研究组 & 干预措施
OTO-413
干预措施: OTO-413 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Otoscopic Examinations (Safety)
时间窗: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Clinically significant change form Baseline
Treatment Emergent Adverse Events (Safety)
时间窗: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)
An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen.
Audiometry (Safety)
时间窗: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Clinically significant change from Baseline
次要结局
未报告次要终点