A Single Ascending Dose Study of BTZ043

This is an interventional treatment trial for Tuberculosis focused on measuring Phase 1, Anti-Bacterial Agents, Respiratory Tract Infections Read More

Inclusion Criteria:

• Provide written informed consent
• Healthy male or female subjects aged between ≥18 and ≤55 years at screening who are able to read, write, and fully understand the German language
• BMI between ≥18 and ≤30 kg/m2, with a body weight between ≥55 and ≤90 kg at screening
• Vital signs within range: pulse rate 50-90 bpm, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mmHg
• No clinically significant findings in laboratory tests
• Women must be of non-childbearing potential, that is, either postmenopausal or premenopausal with documented tubal ligation or hysterectomy or women who are at least 6 weeks post-surgical bilateral oophorectomy
• Male subjects must agree to use a condom with spermicide when engaging in sexual intercourse during the study period and for 2 months after study drug dosing, if they have not had a vasectomy at least 6 months before study start
• Male subjects must not donate sperm during the study and for 2 months after study drug dosing
• Able to swallow the amount of drug in succession
• Agree not to donate blood (or bloodcomponents) until 1 month after receiving study drug
• Normal consumption of alcohol
• Willing to forgo sunbathing and prolonged exposure to sunlight during the study period
• Willing to forgo strenuous exercise from 72 hours prior to admission until discharge

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