Tuberculosis Clinical Trial
Official title:
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
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).
n/a
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