A study to evaluate the safety and pharmacokinetics of DB-020 when administered to healthy participants

Exclusion Criteria23

• Female or male subjects with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after dosing of study drug.
• Sustained supine systolic blood pressure greater than 139 or less than 90 mm Hg and supine diastolic blood pressure greater than 89 or less than 50 mm Hg at screening or any day of admission to the clinical facility.
• Resting heart rate less than 40 beats per minute or greater than 100 beats per minute during screening or on the day of admission to the clinical facility.
• ECG during screening showing corrected QT interval using Fridericia correction formula (QTcF) greater than or equal to 450 msec. In addition, subjects with any other risk factors for QT/QTcF prolongation or any abnormality in the ECG that, in the opinion of the Investigator, increases the risk of participating in the study will be excluded.
• Positive results for drugs of abuse, alcohol, or cotinine in the urine at screening or any day of admission to the clinical facility.
• Positive screening test for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus (HIV) antibodies.
• Use of any medication (prescription or over-the-counter (OTC), including health supplements and herbal remedies, with the exception of acetaminophen as defined below) within 2 weeks (4 weeks for enzyme inducers including St. John’s Wort [Hypericum perforatum]) or 5 half-lives (whichever is longer) before the first dose of study drug.
• Routine or chronic use of more than 2 g of acetaminophen daily.
• Use of any investigational drug or device within 30 days of the first dose of study drug (6 months for biologic therapies) or 5 half-lives of the investigational drug, if known, whichever time period is longer.
• Exposure to excessively loud noise (eg, concerts, loud noise at the workplace) within 24 to 48 hours before Day 1.
• History of donation of more than 450 mL of blood within 60 days before dosing in the clinical research center or planned donation before 30 days have elapsed since intake of study drug. This will be verified by the subject’s hemoglobin and hematocrit values. Subjects with clinically significant abnormalities in hemoglobin/hematocrit will be excluded from the study.
• Plasma, white blood cell, or platelet donation within 7 days of study participation and throughout the study.
• Lack of venous access or inability to tolerate venipuncture as determined by the Investigator or designee.
• History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and/or allergy to the excipients of the study drug.
• Current smoker, currently using e-cigarettes, or discontinuation of smoking or use of e-cigarettes less than 45 days before the first dose of study drug.
• History (within 3 months of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 g of alcohol).
• Any major surgery within 4 weeks of study drug administration.
• History or presence of malignancy within the past 5 years other than past history of localized or surgical removal of focal basal cell skin cancer; cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy.
• Previous participation in the study.
• Signs of disturbed integrity of the tympanic membrane on otoscopy or tympanometry.
• History of congenital hearing loss, ontological surgery (excluding myringotomy tubes), tinnitus (currently experiencing tinnitus or history of tinnitus within 2 months before study enrollment), sudden hearing loss, hearing disorders other than age-related sensorineural hearing loss, Meniere’s disease, middle ear or ear canal inflammation or effusion.
• History of middle ear surgery.
• History of radiotherapy that encompasses all or part of the cochlea.