Safety, Tolerability, and Dose Response of VNA-318 in Healthy Males

"Part 1 will consist of administration of VNA-318 at the doses of 5 mg to 180 mg in 5 successive cohorts.~Part 2 will consist of administration of VNA-318 in 3 successive cohorts. The doses will be selected based on safety and tolerability assessments, aw well as the observed PK and PD data from the SAD part.~For each SAD and MAD cohort, a sentinel group of 2 subjects will initially be randomized to receive VNA-318 or placebo (1:1 ratio)~Once PK suggests that the therapeutic dose has been reached in the SAD part, the SAD and MAD parts of the study could be run in parallel"

"Part 1 (SAD) will consist of administration of matching placebo at the doses of 5 mg to 180 mg in 5 successive cohorts.~Part 2 will consist of administration of matching placebo in 3 successive cohorts. The doses will be selected based on safety and tolerability assessments, aw well as the observed PK and PD data from the SAD part.~For each SAD and MAD cohort, a sentinel group of 2 subjects will initially be randomized to receive VNA-318 or placebo (1:1 ratio)"