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Completed

NCT Number: NCT06391827

A Study to Evaluate Safety, Tolerability, and PK of DA-7503 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

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Key information

Conditions

Healthy

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DA-7503 Single dose

Drug

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

DA-7503 Multiple dose

Drug

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

Drug

Oral administraion for once.

Placebo Multiple dose

Drug

Oral administration once daily for 7 days

Primary outcomes

  1. Pharmacokinetics of DA-7503 single dose oral administration

    Time frame: 5 days

    Peak Plasma Concentration of DA-7503 (Cmax)

  2. Pharmacokinetics of DA-7503 single dose oral administration

    Time frame: 5 days

    Area under the plasma concentration versus time curve of DA-7503 (AUClast)

  3. Pharmacokinetics of DA-7503 multiple dose oral administration

    Time frame: 11 days

    Peak Plasma Concentration of DA-7503 (Cmax)

  4. Pharmacokinetics of DA-7503 multiple dose oral administration

    Time frame: 11 days

    Area under the plasma concentration versus time curve of tau (AUCtau)

  5. Pharmacokinetics of DA-7503 multiple dose oral administration

    Time frame: 11 days

    Peak Plasma Concentration of DA-7503 in steady state (Cmax,ss)

  6. 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)

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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