A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects

Launched by DONG-A ST CO., LTD. · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medicine called DA-5217 behaves in the body when given through an IV (intravenous) in two forms: diluted (mixed with a liquid) and undiluted (not mixed). The main goal is to see how the body absorbs and processes the medicine and to check if it is safe for healthy adults. This is an early-stage study, which means it is mostly focused on safety and how the drug moves through the body rather than treating a disease.

People who might be eligible to join are healthy men and women between 19 and 45 years old, who weigh at least 50 kilograms (about 110 pounds) and have a body weight that is considered normal or slightly overweight. Participants must be free from any serious health problems or drug allergies, not pregnant or breastfeeding, and must agree to take part after understanding all the details of the study. If someone joins, they can expect to receive the medicine through an IV and have their health closely monitored to make sure they do not have any side effects. This study is not yet recruiting participants, so it will start looking for volunteers at a later time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult male or female, 19 years to 45 years
• • Weighing 50 kg or more, with a body mass index (BMI) of 18.5 kg/m2 to 29.9kg/m2
• • The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate and complied with the precautions.
• Exclusion Criteria:
• • The subjects with existing or previous conditions that may influence the pharmacokinetics of drugs
• • The subjects hypersensitive to any of the Investigational Product components or other drug components
• • The subjects with clinically significant active chronic conditions
• • The subjects with a positive urine drug test result or a history of drug abuse or dependence.
• • The subjects who are pregnant or lactating