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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: DA-7503 Single dose; Drug: Placebo Single dose; Drug: DA-7503 Multiple dose; Drug: Placebo Multiple dose

• Registration Number: NCT06391827
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Study Start: 2024-05-07
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
[Single dose] DA-7503	DA-7503 Single dose	6 subjects in each Cohort(Cohort 1-5)
[Single dose] Placebo	Placebo Single dose	2 subjects in each Cohort(Cohort 1-5)
[Multiple dose] DA-7503	DA-7503 Multiple dose	6 subjects in each Cohort(Cohort 1-4)
[Multiple dose] Placebo	Placebo Multiple dose	2 subjects in each Cohort(Cohort 1-4)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of DA-7503 multiple dose oral administration	11 days	Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)
Pharmacokinetics of DA-7503 single dose oral administration	5 days	Area under the plasma concentration versus time curve of DA-7503 (AUClast)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of