First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers

"Single dose of CU06-1004, 7 dose levels, oral capsule : 6 Cohorts (100mg, 300mg, 600mg, 900mg, 1200mg, 300mg bid) + 1 Cohort (Food effect)＊~＊Cohort S7(TBD mg) will receive a single oral dose of CU06-1004 or placebo under fed conditions. When administered under fed conditions, CU06-1004 or placebo will be administered following a high-fat/high-calorie breakfast. Cohort S7 will be conducted following completion of Cohort S5"

"Multiple doses of CU06-1004, 7 days, 3 dose levels＊, oral capsule~＊The dose levels, regimen (i.e., schedule), and conditions (i.e., fasted versus fed conditions) will be determined based on the safety, tolerability, and plasma PK data from SAD"

Placebo matched to CU06-1004, oral capsule