NCT06391827

A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DA-7503 Single dose	Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4 and 5).
DRUG	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, and 4)
DRUG	Placebo Single dose	Oral administraion for once.
DRUG	Placebo Multiple dose	Oral administration once daily for 7 days

Timeline

• Start date: 2024-05-07
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: South Korea