To Evaluate Effect of Food of DA-5222 in Healthy Adult Su... | NCT06993168

Studies
To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects

NCT06993168

Sponsor

Dong-A ST Co., Ltd.

Status

Not yet recruiting

Last Update Posted

May 28, 2025Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

DA-5222

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

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2025Estimated

Primary Completion Date

Jul 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

May 19, 2025

First Submission Date that Met QC Criteria

May 19, 2025

First Posted Date

May 28, 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

May 19, 2025

Last Update Posted Date

May 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A	Experimental		Drug: DA-5222
Sequence B	Experimental		Drug: DA-5222

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5222	Drug	single dose administration (DA-5222 one tablet once a day)	Sequence A Sequence B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt	area under the curve	pre-dose~72 hours post-dose
Cmax	maximum plasma concentration	pre-dose~72 hours post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
Subjects with allergy or drug hypersensitivity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jihyun Sung	Contact	+82-02-920-8369		jhsung@donga.co.kr
Heechan Jung	Contact	+82-02-920-8322		hcjung@donga.co.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bumin Hospital		Seoul	South Korea		South Korea