A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea

Exclusion Criteria

• •Excluded Disease
• •1. Patients diagnosed with otitis media with cholesteatoma, otitis media with effusion or otitis externa at screening
• •2. Patients who had a otologic surgery within 1 year prior to screening (except for tympanostomy tube insertion)
• •3. Subjects who previously had cholesteatoma or mastoid surgery
• •Medical History and Concurrent Disease
• •1. Patients with complication of labyrinthine fistula at screening
• •2. Patients with clinically significant medical or mental illness.
• •3. Patients with infectious disease requiring the use of systemic antimicrobial therapy
• •Physical and Laboratory Test Results
• •a)Clinically significant finding based on the principal investigator/investigator's opinion.
• •Allergies and Adverse Drug Reactions
• •1. Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity)
• •2. History of hypersensitivity to penicillins or -lactamase inhibitors.
• •3. History of serious skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrosis
• •Prohibited Therapies and/or Medication
• •1. Patients undergoing a ventilation tube insertion on the day of screening
• •2. Patients with ventilation tube containing silver oxide or silver salt (e.g., T-type tube)
• •Reproductive status, Women only
• •a)Woman of childbearing potential (WOCBP) who is unable, or unwilling to use an acceptable method of contraception during the study
• •1. History of alcohol or drug abuse/addiction within the last 1 year prior to the study entry
• •2. Patient who, in the investigator's opinion, is not suitable for the study for any reason (e.g., ECG or hepatitis test results at screening)