A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants
NCT ID: NCT06391827
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2024-05-07
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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[Single dose] DA-7503
6 subjects in each Cohort(Cohort 1-5)
DA-7503 Single dose
Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4 and 5).
[Single dose] Placebo
2 subjects in each Cohort(Cohort 1-5)
Placebo Single dose
Oral administraion for once.
[Multiple dose] DA-7503
6 subjects in each Cohort(Cohort 1-4)
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)
[Multiple dose] Placebo
2 subjects in each Cohort(Cohort 1-4)
Placebo Multiple dose
Oral administration once daily for 7 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²
Exclusion Criteria
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)
19 Years
85 Years
ALL
Yes
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seung Hwan Lee, PhD
Role: primary
Other Identifiers
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DA7503_AD_Ia
Identifier Type: -
Identifier Source: org_study_id