A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)
Trial ID or NCT#
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.
A Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical Application Into the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)
- - 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: - Not a woman of childbearing potential (WOCBP) OR - WOCBP who agrees to follow the contraceptive guidance starting at screening and for at least 28 days after investigational product (IP) application. - 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 refraining from using prohibited concomitant medications. - Subject agrees not to participate in another interventional study during the study period.
- - 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. - Active 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 hertz (Hz). - Only hearing ear or better hearing ear and the contralateral ear ≥ 40 dB (decibels) by average four-frequency (500, 1000, 2000 and 4000 Hz). - 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.