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Completed

NCT Number: NCT07027982

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

This study will evaluate the pharmacokinetics and safety of Diluted and Undiluted Intravenous DA-5217 in healthy adult subjects.

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Key information

Conditions

Healthy Adults

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13605, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diluted Intravenous DA-5217

Drug

once a day

Undiluted Intravenous DA-5217

Drug

once a day

Primary outcomes

  1. AUClast

    Time frame: 0~24hours

    Area under the plasma concentration-time curve from time zero to time the last quantifiable time

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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