Tuberculosis Clinical Trial
Official title:
Safety, Tolerability, Pharmacokinetic Profile and Ex-vivo Antitubercular Activity of PBTZ169 Formulated as Spray- Dried Dispersion Versus Native Crystal Powder: Single Ascending Doses, Randomized, Placebo- Controlled, Cross-over Phase Ia Trial in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted
at one study center in Switzerland.
Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each undergoing 2
investigation periods and receiving either single doses of PBTZ169 at increasing dose levels
or a matching placebo.
Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment,
1 under placebo) will be investigated in parallel. Panels A and B are interleaved.
Safety will be assessed throughout the study; serial ECGs and serial blood samples will be
collected for the safety and PK assessment of PBTZ169.
Dose escalation will be allowed once the Trial Safety Board has determined that adequate
safety and tolerability after panel B and panel C completion has been demonstrated to permit
proceeding to the next panel.
n/a
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