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

Launched by DONG-A ST CO., LTD. · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called DA-7503 to see how safe it is, how well it can be tolerated, and how the body processes it. The trial will involve healthy adults and older adults and will compare the medication to a placebo, which is a dummy treatment that looks like the real thing but has no active ingredients. The study will take place in two groups: younger adults aged 19 to 55 and older adults aged 65 to 85.

To be eligible for this trial, participants need to be healthy, weigh at least 50 kg, and have a body mass index (BMI) between 18 and 30. However, people with certain medical conditions, allergies, or those who smoke heavily, consume a lot of caffeine, or drink excessive alcohol will not be able to participate. Participants can expect to take the medication in different doses, and researchers will monitor their health closely throughout the study. The trial is not yet recruiting participants, so there is no need to apply just yet.

Gender

ALL

Eligibility criteria

• 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)