The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.

Inclusion Criteria:

• Healthy male volunteers aged 20 to 40 years.
• Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.

Exclusion Criteria:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

Safety Analysis Set: subjects who received the investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.

Treatment-emergent adverse events occurring up to 8 days after dosing date were collected.

A single dose of ASC-01 placebo or sertraline tablet was administered to 25 subjects each in Period I, and a single dose of ASC-01 placebo or sertraline tablet was administered to 21 and 23 subjects, respectively, in Period II. In this trial, safety data for each formulation were summarized based on subjects treated with the respective formulation, and safety was therefore evaluated in 46 subjects receiving ASC-01 placebo and 48 subjects receiving sertraline tablets.