NCT07618845

Brief Summary

A clinical trial to assess the pharmacokinetics, safety, and food effect 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
24

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

May 1, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 26, 2026

Last Update Submit

May 26, 2026

Conditions

Chronic Liver Disease (CLD)

Outcome Measures

Primary Outcomes (2)

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

    -24hours to 72hours

  • Maximum concentration of drug in plasma (Cmax)

    -24hours to 72hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Fasted, Period 2: Fed

Drug: AD-230 (Fasted)Drug: AD-230 (Fed)

Sequence B

EXPERIMENTAL

Period 1: Fed, Period 2: Fasted

Drug: AD-230 (Fasted)Drug: AD-230 (Fed)

Interventions

AD-230 (Fasted)DRUG

AD-230 1Tab., Per Oral, Fasted

Sequence ASequence B
AD-230 (Fed)DRUG

AD-230 1 Tab., Per Oral, Fed state

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

Daegu, 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

May 26, 2026

First Posted

June 1, 2026

Study Start

May 1, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)