Safety and Tolerability Study of N6022 in Healthy Subjects

This is a single dose escalation, first-time-in-human study with three ascending cohorts.
Eligible subjects will receive a single dose of investigational medicinal product or placebo
on Day 1 and will be followed for safety, PK, and PD for 72 hours post dose. Follow-up
visits on Day 4 and Day 7 for the end-of-study safety. Participation of an individual
subject may last up to 36 days from the time of screening until the end-of-study follow-up
visit. Each cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These
subjects will be followed for 48 hours postdose and safety data reviewed before the
remaining subjects in the cohort receive IMP. A Safety Monitoring Committee will review the
seven-day safety data in each cohort before proceeding to the next ascending dose cohort,
according to the stopping rules outlined in the protocol.