A Phase 1 Study of Usynova Pharmaceuticals UA021 in healthy participants for the evaluation of safety, tolerability, and drug concentration in progressively increasing single and multiple daily dose levels

UA021-AU001 is a two-part study within which parts 1 and 2 will be conducted sequentially. Each study part and stage will involve unique participants. Part A: Single ascending dose cohorts Part A evaluates the single-dose administration of UA021 or matched placebo (a capsule that looks the same as the study drug but has no active substances): 5mg, 15mg, 30mg, 60mg, and 120mg respectively in cohorts 1-5. Each cohort will consist of 8 participants who will each receive a single dose of investigational drug or matched placebo under fasted state (after an overnight fast of at least 8 hours prior to dosing), Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff. Each of the SAD cohorts will be observed for at least 14 days. Safety, tolerability, and available PK data will be reviewed by the SRC for dose escalation and the actual doses to be administered may be adjusted accordingly. Part B: Multiple ascending dose cohorts Each cohort will consist of 8 participants who will each receive UA021 or matched placebo (a capsule that looks the same as the study drug but has no active substances): 15mg, 30mg, and 60mg given by oral administration twice daily for 14 days. after an overnight fast of at least 8 hours prior to morning dosing and, a 1 hour fast prior to the evening dose. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff. The actual starting dose including dose regimen for Part B and conditions for the administration of the study intervention will determined by SRC after reviewing of the safety, tolerability, and available PK data of Part A. Part B may be initiated prior to or after the completion of Part A at the discretion of the SRC. In Part B, after an observation period of at least 28 days (from the first day of dosing) and review of the safety, tolerability, and available PK data of all participants enrolled in the previous cohorts, the next actual dose cohort may be adjusted by the SRC. These dose adjustments may involve either an increase or a decrease in the planned dose or a change in the dosing frequency.