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

May 19, 2026 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy volunteers(Age: 19~55 years, 65~85 years)
  2. Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²

Exclusion Criteria:

  1. Clinically significant Medical History
  2. Allergy or Drug hypersensitivity
  3. AST, ALT, Total billurbin > Upper Normal Range*1.5, eGFR<60mL/min/1.73m²
  4. Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
  5. Heavy smoker(more than 10 cigarettes/day)
  6. Heavy caffeine intake(more than 5 units/day)
  7. Heavy alcohol intake(more than 210g/week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [Single dose] DA-7503
6 subjects in each Cohort(Cohort 1-6)
Drug: DA-7503 Single dose
Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4, 5 and 6).
Placebo Comparator: [Single dose] Placebo
2 subjects in each Cohort(Cohort 1-6)
Drug: Placebo Single dose
Oral administraion for once.
Experimental: [Multiple dose] DA-7503
6 subjects in each Cohort(Cohort 1-5)
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, 4 and 5)
Placebo Comparator: [Multiple dose] Placebo
2 subjects in each Cohort(Cohort 1-5)
Drug: Placebo Multiple dose
Oral administration once daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of DA-7503 single dose oral administration
Time Frame: 5 days
Peak Plasma Concentration of DA-7503 (Cmax)
5 days
Pharmacokinetics of DA-7503 single dose oral administration
Time Frame: 5 days
Area under the plasma concentration versus time curve of DA-7503 (AUClast)
5 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Time Frame: 11 days
Peak Plasma Concentration of DA-7503 (Cmax)
11 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Time Frame: 11 days
Area under the plasma concentration versus time curve of tau (AUCtau)
11 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Time Frame: 11 days
Peak Plasma Concentration of DA-7503 in steady state (Cmax,ss)
11 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Time Frame: 11 days
Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Actual)

January 12, 2026

Study Completion (Actual)

January 12, 2026

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DA7503_AD_Ia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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