NCT06884098

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

March 10, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

22 days

First QC Date

March 13, 2025

Last Update Submit

March 18, 2025

Conditions

Primary Hypercholesterolaemia

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-228B

    pre-dose (0hour) to 72hours

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

    AUCt of AD-228B

    pre-dose (0hour) to 72hours

Study Arms (2)

Sequence A (RT)

EXPERIMENTAL

Period 1: Reference Drug (AD-2284), Period 2: Test Drug (AD-228B)

Drug: AD-228BDrug: AD-2284

Sequence B (TR)

EXPERIMENTAL

Period 1: Test Drug (AD-228B), Period 2: Reference Drug (AD-2284)

Drug: AD-228BDrug: AD-2284

Interventions

AD-228BDRUG

AD-228B, 1Tab., Per Oral

Sequence A (RT)Sequence B (TR)
AD-2284DRUG

AD-2284, 1Tab., Per Oral

Sequence A (RT)Sequence B (TR)

Eligibility Criteria

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

You may qualify if:

  • Body weight equal to or greater than 50kg (Female 45kg) and 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 other 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 Plus Yangji Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

JeongEun Park

CONTACT

+82-31-891-6989parkje@addpharma.co.kr

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

March 13, 2025

First Posted

March 19, 2025

Study Start

March 10, 2025

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)