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正在招募
安斯泰来研究编号
0598-CL-0101

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

安斯泰来研究编号
0598-CL-0101
Clinicaltrials.gov 登记号
NCT04305184
EUCTIS 编号
N/A
EudraCT 编号
N/A
jRCT ID
N/A
CN CDE ID
N/A
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试验摘要

The primary purpose of this study is to evaluate the safety and tolerability of ASP0598 Otic Solution. This study will also evaluate the efficacy of ASP0598 otic solution.

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研究分期
Phase 1/Phase 2
研究产品
ASP0598
研究产品
ASP0598
Matching Placebo
研究类型
干预性
盲法
Double (Participant, Investigator)
入组人数
114
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    试验信息
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    参与者年龄
    18 - 65 years
    Diamond icon
    疾病
  • 鼓膜穿孔（破裂）
    • Gender icon
    参与者性别
    女性和男性
    Calendar icon
    试验开展时间
    2020年9月 - 2023年3月
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    入选标准
    • Subject has chronic tympanic membrane perforation (CTMP) documented as persisting longer than 3 months.
    • A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
      • 非有生育能力的女性 (WOCBP) 或者
      • WOCBP who agrees to follow the contraceptive guidance starting at screening and for at least 28 days after investigational product (IP) application on Day 1.
    • Female subject must agree not to breastfeed starting at drug application on Day 1 and for at least 28 days after IP application.
    • Female subject must not donate ova starting on Day 1 and for at least 28 days after investigational product (IP) application.
    • A male subject with female partner(s) of child-bearing potential must agree to use contraception starting on Day 1 and for at least 28 days after IP application.
    • A male subject must not donate sperm starting on Day 1 and for at least 28 days after IP application.
    • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom from Day 1 and for at least 28 days after IP application.
    • Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
    • Subject agrees not to participate in another interventional study while receiving IP.
    Maximize排除标准
    • Subject has one of following conditions that may affect the ipsilateral side of the ear with chronic tympanic membrane perforation (CTMP):
      • Perforation involving 3 or more quadrants.
      • Pin hole perforation (only for the expansion cohort).
      • Presence of tympanosclerosis adjacent to the perforation.
      • Perforation involves malleus erosion.
      • Absent malleus.
      • Marginal perforation (i.e., involving the annulus or exposing the handle of malleus).
      • Tympanic membrane perforation (TMP) caused by electric/slag/blast/burn injury.
      • Post radiated TMP.
      • History of tympanic membrane repair by any type of live tissue.
      • History of otorrhea or active treatment for otorrhea within the last 3 months prior to Screening.
      • Bellucci otorrhea grade 3 or above.
      • Active external ear canal inflammation (otitis externa, dermatitis) or within the last 3 months prior to Screening.
      • Active diagnosis of Eustachian Tube dysfunction or diagnosis within 6 months prior to Screening.
      • Craniofacial abnormalities, History of head and neck surgery within the last 3 months prior to Screening, history of radiation to head and neck.
      • Recent (within 2 weeks) diagnosis of upper respiratory tract infection.
      • Presence or history of cholesteatoma.
      • Presence of pars-flaccida or pars tensa retraction or adhesion.
      • Presence or history of tumors of the middle or external ear.
      • Contraindications to tympanic membrane closure.
      • An audiometric finding indicates a characteristic of Carhart's notch which is an increase in bone conduction threshold with a peak at 2,000 Hz.
      • Only hearing or better hearing ear.
      • Whole circumference of the tympanic membrane perforation is not visible by endoscope.
      • Presence/history of eosinophilic otitis media in either ear.
    • Subject has a presence of adhesive otitis media in the contralateral ear.
    • Subject has a presence of any wound healing systemic condition.
    • Subject has Obstructive Sleep Apnea where the subject is required to use Continuous Positive Airway Pressure (CPAP) during the study period.
    • Subject is exposed in their daily life to high volume of water into the ear canal (e.g., swimmer or surfer).
    • Subject has health conditions that would prevent him/her from fulfilling the study requirements on the basis of medical history and laboratory test (Serum Chemistries, complete blood count [CBC] with Differential, Urinalysis) results at the screening visit.
    • Subject is receiving any other investigational agents during study participation.
    • Subject has any form of substance abuse, or psychiatric illness/social situations that would limit compliance with study requirements, or a condition that could invalidate communication.
    • Subject has a known or suspected hypersensitivity to ASP0598, or any components of the formulation used.
    • Subject has had previous exposure with ASP0598.
    • Subject is unlikely to comply with the visits scheduled in the protocol.

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