NCT07521241

Brief Summary

A Clinical Trial to Evaluate the Pharmacokinetics and Safety of AD-230 in Healthy Adults

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 3, 2026

Last Update Submit

April 8, 2026

Conditions

Chronic Liver Disease (CLD)

Outcome Measures

Primary Outcomes (2)

  • AUClast

    -24hours to 72hours

  • Cmax

    -24hours to 72hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1 : Reference drug(AD-2301), Period 2 : Test drug(AD-230) Single oral dose administration of AD-2301 three times in Period 1, followed by single oral dose administration of AD-230 twice in Period 2.

Drug: AD-230, AD-2301

Sequence B

EXPERIMENTAL

Period 1 : Test drug(AD-230), Period 2 : Reference drug(AD-2301) Single oral dose administration of AD-230 twice in Period 1, followed by single oral dose administration of AD-2301 three times in Period 2

Drug: AD-230, AD-2301

Interventions

AD-230, AD-2301DRUG

Oral administration of AD-230 or AD-2301, according to randomized sequence.

Sequence ASequence B

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
  • Subjects aged 19 years or older and under 65 years at the 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)

Kyungpook National university hospital

Seoul, South Korea

Location

Central Study Contacts

Sarah Yoon

CONTACT

031-891-5576sryoon@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

April 3, 2026

First Posted

April 9, 2026

Study Start

May 1, 2026

Primary Completion

June 1, 2026

Study Completion

July 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)