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

Dong-A ST

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-7503 Multiple dose; Drug: Placebo Multiple dose; Drug: Placebo Single dose; Drug: DA-7503 Single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06391827

DA7503_AD_Ia

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

[Single dose] DA-7503

Experimental group

Description:

6 subjects in each Cohort(Cohort 1-5)

Treatment:

Drug: DA-7503 Single dose

[Single dose] Placebo

Placebo Comparator group

Description:

2 subjects in each Cohort(Cohort 1-5)

Treatment:

Drug: Placebo Single dose

[Multiple dose] DA-7503

Experimental group

Description:

6 subjects in each Cohort(Cohort 1-4)

Treatment:

Drug: DA-7503 Multiple dose

[Multiple dose] Placebo

Placebo Comparator group

Description:

2 subjects in each Cohort(Cohort 1-4)

Treatment:

Drug: Placebo Multiple dose