NCT06858865

Brief Summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_1

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

February 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 12, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

February 28, 2025

Last Update Submit

September 30, 2025

Conditions

Primary Hypercholesterolaemia

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-228A

    pre-dose to 72 hours

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-228A

    pre-dose to 72 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1 : Reference Drug(AD-2281 and AD-2282), Period 2 : Test Drug(AD-228A)

Drug: AD-228ADrug: AD-2281 and AD-2282

Sequence B

EXPERIMENTAL

Period 1 : Test Drug(AD-228A), Period 2 : Reference Drug(AD-2281 and AD-2282)

Drug: AD-228ADrug: AD-2281 and AD-2282

Interventions

AD-228ADRUG

AD-228A Oral Tablet

Sequence ASequence B
AD-2281 and AD-2282DRUG

AD-2281 Oral Tablet + AD-2282 Oral Tablet

Sequence ASequence B

Eligibility Criteria

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

You may qualify if:

  • Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

You may not qualify if:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H+ Yangji 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

February 28, 2025

First Posted

March 5, 2025

Study Start

July 12, 2025

Primary Completion

August 14, 2025

Study Completion

August 14, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)