A Single Ascending Dose Study of BTZ043

Exclusion Criteria

• •Any known chronic systemic viral infection
• •Any relevant systemic infection or other systemic illness
• •Vaccination 30 days prior to drug administration
• •Known hypersensitivity to any of the excipients of the study drug
• •A clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history or any other medical condition
• •History of or current alcohol or illicit drug abuse
• •Positive results in the urine drug screen or blood alcohol test at admission
• •Current or recent (within the past 3 months before drug administration) use of tobacco or other nicotine-containing product or positive results of cotinine test at screening or admission
• •Use of any prescription or over-the-counter (OTC) drug or herbal product within 14 days before drug administration with exception for sporadic use of ibuprofen or paracetamol for example in case of pain
• •Use of any known drug metabolism enzyme-altering drug or supplement within 14 days before dosing or consumption of foods or beverages containing grapefruit within 48 hours before admission
• •ECG findings in the screening ECG of QTcF-interval over 450 ms; atrioventricular (AV) block with PR-interval over 200 ms, prolongation of the QRS complex over 120 ms, or other changes in the ECG that are clinically relevant as per discretion of the investigator
• •Long QT syndrome, or family history of long QT syndrome or sudden death of unknown or cardiac-related cause
• •Use or planned necessary use of any QT-prolonging agents
• •Participation in another investigational drug study within the previous 30 days before drug administration
• •Any donation of blood, plasma, or platelets or significant loss of blood within the previous 30 days before drug administration
• •Previous randomization in this study
• •Volunteer unwilling or unable to comply with protocol requirements in the judgment of the investigator
• •Vulnerable subject (e.g. person is kept in detention)
• •Employees of the sponsor or subjects who are employees or relatives of the investigator