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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07027982

Enrollment

Registered

2025-06-19

Start date

2025-07-16

Completion date

2025-08-14

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Brief summary

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

Interventions

DRUGDiluted Intravenous DA-5217

once a day

DRUGUndiluted Intravenous DA-5217

once a day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUClast	0~24hours	Area under the plasma concentration-time curve from time zero to time the last quantifiable time

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026