Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

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

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DA-5221_01 and its safety and how the body processes it when given alone or in combination with two other substances (5221_01-R1 and DA-5221_01-R2). The goal is to find out if this treatment is safe for healthy adults. The trial is currently not recruiting participants, but when it starts, it will involve healthy volunteers between the ages of 18 and 39 who have a body mass index (BMI) between 18 and 30, and meet specific weight requirements.

To participate, individuals must be in good health and will need to sign a consent form after receiving detailed information about the study. However, people with significant medical issues or a history of drug abuse will not be eligible to join. Participants in this trial can expect to undergo monitoring to ensure their safety and to help researchers understand how the treatment works in the body. This study is an important step in evaluating new treatments that could potentially benefit patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy volunteers
• • BMI between 18 and 30 kg/m2
• • Body weight: Male≥50kg, Female≥45kg
• • Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
• Exclusion Criteria:
• • Subjects with clinically significant medical history
• • Subjects with history of drug abuse or addicted