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Astellas CTMP

Title 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)
Therapeutic Area Chronic Tympanic Membrane Perforation
Principal Investigator Jonathon Sillman, MD
Min Age 18 Years
Max Age 65 Years
Gender All
Contact Lauren Tobias
617-636-4714
ltobias1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04305184

Overview

This study is for people who have a tear in their ear drum that has lasted longer than 3 months (chronic tympanic membrane perforation, or CTMP). It is looking at the ability of an investigational drug, ASP0598 Otic Solution, to close ear drum tears when given as ear drops. This study will consist of multiple arms, in which study participants will be randomly placed. Some participants will receive one dose of the study drug, some will receive multiple doses, and some will receive a placebo. Neither the participant nor the study team will know what was received.

Study Details

Inclusion Criteria

  • Subjects must have a tear in their ear drum (chronic tympanic membrane perforation, or CTMP) that has lasted longer than 3 months.
  • Female subjects who are of childbearing age must be on some form of birth control throughout the study, male subjects with female partners of childbearing potential must use contraception throughout the study.
  • Female subjects must agree not to breastfeed throughout the study

Exclusion Criteria

  • Subject has a condition that affects their body’s ability to heal wounds.
  • Subject has Obstructive Sleep Apnea (a condition that causes brief involuntary stops in breathing during sleep) that requires the use of continuous air pressure to keep the airways open, typically through the use of a CPAP machine.
  • Subject has an infection in the ear opposite the one with the tympanic membrane perforation.

Study Requirements

Study participation will take approximately 2-4 months and include approximately 8 visits to the clinic. Study visits may include ear exams and imaging, physical exams, height and weight measurements, monitoring of vital signs (blood pressure, temperature, heart rate, and breathing rate), blood collection, urine sample collection, and study drug administration. Blood collection for lab tests will occur at either 4 or 5 of the visits, with about 1 teaspoon of blood collected each time.