Start of Phase Ia Clinical Trial with PBTZ169

This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in Switzerland.

Four panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each undergoing two 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.

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