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A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants
Sponsor: Dong-A ST Co., Ltd.
Summary
This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants
Official title: A Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Orally Administered DA-7503 After Single and Multiple Ascending Dose Regimens in Healthy Adult and Elderly Participants
Key Details
Gender
All
Age Range
19 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-05-27
Completion Date
2026-01-12
Last Updated
2026-05-22
Healthy Volunteers
Yes
Conditions
Interventions
DA-7503 Single dose
Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4, 5 and 6).
DA-7503 Multiple dose
Oral administration once daily for 7 days; Dose strength or target volunteer is different for each cohort(Cohort 1, 2, 3, 4 and 5)
Placebo Single dose
Oral administraion for once.
Placebo Multiple dose
Oral administration once daily for 7 days
Locations (1)
Seoul National University Hospital
Seoul, South Korea