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

Dong-A ST Co., Ltd.90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

DA-7503 Single doseDRUG

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

DA-7503 Multiple doseDRUG

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 doseDRUG

Oral administraion for once.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Pharmacokinetics of DA-7503 single dose oral administration

Peak Plasma Concentration of DA-7503 (Cmax)

Time frame: 5 days

Pharmacokinetics of DA-7503 single dose oral administration

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

Time frame: 5 days

Pharmacokinetics of DA-7503 multiple dose oral administration

Peak Plasma Concentration of DA-7503 (Cmax)

Time frame: 11 days

Pharmacokinetics of DA-7503 multiple dose oral administration

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

Time frame: 11 days

Pharmacokinetics of DA-7503 multiple dose oral administration

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

Time frame: 11 days

Pharmacokinetics of DA-7503 multiple dose oral administration

Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)

Time frame: 11 days

Data from ClinicalTrials.gov

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