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

NCT06391827 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: DA7503_AD_Ia
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics of DA-7503 single dose oral administration

  Peak Plasma Concentration of DA-7503 (Cmax)

  5 days

• Pharmacokinetics of DA-7503 single dose oral administration

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

  5 days

• Pharmacokinetics of DA-7503 multiple dose oral administration

  Peak Plasma Concentration of DA-7503 (Cmax)

  11 days

• Pharmacokinetics of DA-7503 multiple dose oral administration

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

  11 days

• Pharmacokinetics of DA-7503 multiple dose oral administration

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

  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)

  11 days

Study Arms (4)

[Single dose] DA-7503

EXPERIMENTAL

6 subjects in each Cohort(Cohort 1-5)

Drug: DA-7503 Single dose

[Single dose] Placebo

PLACEBO COMPARATOR

2 subjects in each Cohort(Cohort 1-5)

Drug: Placebo Single dose

[Multiple dose] DA-7503

EXPERIMENTAL

6 subjects in each Cohort(Cohort 1-4)

Drug: DA-7503 Multiple dose

[Multiple dose] Placebo

PLACEBO COMPARATOR

2 subjects in each Cohort(Cohort 1-4)

Drug: Placebo Multiple dose

Interventions

DA-7503 Single dose DRUG

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

[Single dose] DA-7503

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, and 4)

[Multiple dose] DA-7503

Placebo Single dose DRUG

Oral administraion for once.

[Single dose] Placebo

Placebo Multiple dose DRUG

Oral administration once daily for 7 days

[Multiple dose] Placebo

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Central Study Contacts

Seung Hwan Lee, PhD

CONTACT

82-2-2072-2343; leejh413@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 30, 2024
• Study Start: May 7, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

KR (1)