NCT07297940

Brief Summary

This clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 at fasting state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2025

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 9, 2025

Last Update Submit

March 26, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Area Under the Curve

    pre-dose~72 hours post-dose

  • Cmax

    Maximum Plasma Concentration

    pre-dose~72 hours post-dose

Study Arms (2)

Sequence A

EXPERIMENTAL
Drug: DA-1229_01Drug: DA-1229_01-R

Sequence B

EXPERIMENTAL
Drug: DA-1229_01Drug: DA-1229_01-R

Interventions

DA-1229_01DRUG

single dose administration (DA-1229 one tablet once a day)

Sequence ASequence B
DA-1229_01-RDRUG

single dose administration (DA-1229\_01-R one tablet once a day)

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with clinically significant medical history
  • Subjects with history of drug abuse or addicted
  • Subjects with allergy or drug hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bumin hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

December 14, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

KR(1)