Primary Objective of this study will be to evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses (SAD/MAD) in healthy subjects.~This is a single center, Phase 1, Randomized, Double-blind, Placebo controlled, sequential SAD/MAD study, with a food-effect arm. The study will be divided into three parts:~SAD cohorts~MAD cohorts~Food-effect cohort The three parts will be completed sequentially.~SAD Part:~Consist of at least 4 cohorts (1 cohort per dose level).~Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo).~A staggered dosing schedule will be used for dosing of each cohort (under fasting conditions)~MAD Part:~Consist of up to 4 cohorts (1 cohort per dose level).~Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo).~The cohorts will be dosed sequentially in an ascending fashion.~The dose of MAD cohorts is dependent on the available safety, tolerability, and PK data from the SAD part and available safety, tolerability, and PK data from dosed MAD cohorts.~Food-effect Part:~1. Approximately twelve (12) participants will be randomized in a 1:1 ratio to one of two treatment sequences (fast-fed/fed-fast) with 6 participants per treatment sequence.
The goal of this clinical trial is to test the ATH-063 drug (single and multiple doses) in Healthy Subjects. The clinical trial aims to evaluate the below.~Safety of the drug~Tolerability of the drug~Pharmacokinetics (PK) (how the human body affects the drug)~Pharmacodynamics (PD) (how the drug affects the human body)~This will be a single center, Phase 1, First-In-Human, Randomized, Double-Blind (neither the subjects nor the experimenters know which subjects are in the test and control groups), Placebo (a look-alike substance that contains no active drug) - Controlled Study.