NCT07538466

Brief Summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232

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
50

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Apr 2026

Shorter than P25 for phase_1 diabetes-mellitus

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

April 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 12, 2026

Last Update Submit

April 12, 2026

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-123

    pre-dose to 72 hours

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

    AUCt of AD-123

    pre-dose to 72 hours

Study Arms (2)

Sequence A (RT)

EXPERIMENTAL

Period 1 : Reference Drug(AD-1231 and AD-1232), Period 2 : Test Drug(AD-123)

Drug: AD-123Drug: AD-1231 and AD-1232

Sequence B (TR)

EXPERIMENTAL

Period 1 : Test Drug(AD-123), Period 2 : Reference Drug(AD-1231 and AD-1232)

Drug: AD-123Drug: AD-1231 and AD-1232

Interventions

AD-1231 and AD-1232DRUG

AD-1231 Oral Tablet + AD-1232 Oral Tablet

Sequence A (RT)Sequence B (TR)
AD-123DRUG

AD-123 Oral Tablet

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 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 Plus Yangji Hospita

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Dasom Kim

CONTACT

+82-31-891-5572dskim@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 12, 2026

First Posted

April 20, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)