a single ascending dose study of btz043

Conditions: Tuberculosis; Tuberculosis, Pulmonary; Bacterial Infections; Lung Diseases; Mycobacterium Infections

Summary: this study is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics of single doses of btz043 in healthy adult volunteers. the study is conducted at a study centre in germany. up to 50 male and female participants will be included in this study in up to 5 cohorts; each cohort will consist of 10 subjects: in each cohort 8 subjects will be assigned to btz-043 and 2 to placebo. the doses tested will be: 125mg, 250mg, 500mg, 1000mg and 2000mg. safety will be assessed via regular vital sign measurement, 12-lead ecg parameters, physical examination and safety laboratory assessments. subjects will be hospitalized from day -1 until discharge in the morning of day 3. after completion of all day 3 assessments of a cohort, blinded safety data will be reviewed and the next dose increment will be decided by the trial steering committee (tsc).


Eligibility criteria:
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

Keywords: phase 1 anti-bacterial agents respiratory tract infections