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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391827
• Other study ID #: DA7503_AD_Ia
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 7, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: Dong-A ST Co., Ltd.
• Contact: Seung Hwan Lee, PhD
• Phone: 82-2-2072-2343
• Email: leejh413[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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