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A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants
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What is being tested
DA-7503 Single dose+ DA-7503 Multiple dose+ Placebo Single dose
Drug
Who is being recruted
Healthy
From 19 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed
Treatment Study
Placebo-Controlled
Phase 1
Interventional
Study Start: May 2024
See protocol details
Summary
Principal SponsorDong-A ST Co., Ltd.
Study ContactSeung Hwan Lee, PhD
Last Updated April 30, 2024Sourced from a government-validated database.Claim as a partner
Study start date May 7, 2024Actual date on which the first participant was enrolled.
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
Principal SponsorDong-A ST Co., Ltd.
Study ContactSeung Hwan Lee, PhD
Last Updated April 30, 2024Sourced from a government-validated database.Claim as a partner
ProtocolThis section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
72 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.
Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.
Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.
How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
EligibilityResearchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 19 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy
Criteria
2 inclusion criteria required to participate
Healthy volunteers(Age: 19\~55 years, 65\~85 years)
Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²
7 exclusion criteria prevent from participating
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)
Show More Criteria
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.
Study PlanFind out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental
6 subjects in each Cohort(Cohort 1-5)
Group II
Placebo
2 subjects in each Cohort(Cohort 1-5)
Group III
Experimental
6 subjects in each Cohort(Cohort 1-4)
Group IV
Placebo
2 subjects in each Cohort(Cohort 1-4)
Study Objectives
Primary Objectives
Peak Plasma Concentration of DA-7503 (Cmax)
Area under the plasma concentration versus time curve of DA-7503 (AUClast)
Peak Plasma Concentration of DA-7503 (Cmax)
Area under the plasma concentration versus time curve of tau (AUCtau)
Peak Plasma Concentration of DA-7503 in steady state (Cmax,ss)
Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)
Study CentersThese are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Seoul National University HospitalSeoul, Korea, Republic of
Recruiting soonOne Study Center