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

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06391827

Enrollment

Registered

2024-04-30

Start date

2024-05-27

Completion date

2026-01-12

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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

Interventions

DRUGDA-7503 Single dose

Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4, 5 and 6).

DRUGDA-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)

DRUGPlacebo Single dose

Oral administraion for once.

DRUGPlacebo Multiple dose

Oral administration once daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 85 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics of DA-7503 single dose oral administration	5 days	Peak Plasma Concentration of DA-7503 (Cmax)
Pharmacokinetics of DA-7503 multiple dose oral administration	11 days	Peak Plasma Concentration of DA-7503 (Cmax)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026