A Study to Evaluate the Pharmacokinetics and Safety of Di... | NCT07027982

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

NCT07027982

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Aug 22, 2025Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Adults

Interventions

Diluted Intravenous DA-5217
Undiluted Intravenous DA-5217

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2025Actual

Primary Completion Date

Aug 14, 2025Actual

Completion Date

Aug 14, 2025Actual

First Submitted Date

Jun 11, 2025

First Submission Date that Met QC Criteria

Jun 11, 2025

First Posted Date

Jun 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2025

Last Update Posted Date

Aug 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1	Experimental		Drug: Diluted Intravenous DA-5217 Drug: Undiluted Intravenous DA-5217
Sequence 2	Experimental		Drug: Diluted Intravenous DA-5217 Drug: Undiluted Intravenous DA-5217

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diluted Intravenous DA-5217	Drug	once a day	Sequence 1 Sequence 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13605	South Korea