NCT07730567

Brief Summary

To evaluate the pharmacokinetic interaction and the safety of AD-236A and AD-236B in healthy adult volunteers

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
2mo left

Started Jul 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 Progress6%
Jul 2026Sep 2026

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 29, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2026

Expected
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Diabete Type 2Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • 1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)

    AUCτ,ss

    pre-dose (0hour) to 24 hours post-dose

  • Maximum concentration of drug in plasma at steady state (Cmax,ss)

    Cmax,ss

    pre-dose (0hour) to 24 hours post-dose

Study Arms (2)

Arm A

EXPERIMENTAL

Period 1 : Treatment A(AD-236A), Period 2 : Treatment C(AD-236A+AD-236B)

Drug: Treatment A(AD-236A)Drug: Treatment C(AD-236A+AD-236B)

Arm B

EXPERIMENTAL

Period 1 : Treatment B(AD-236B), Period 2 : Treatment C(AD-236A+AD-236B)

Drug: Treatment B(AD-236B)Drug: Treatment C(AD-236A+AD-236B)

Interventions

Treatment A(AD-236A)DRUG

AD-236A Oral Tablet

Arm A
Treatment B(AD-236B)DRUG

AD-236B Oral Tablet

Arm B
Treatment C(AD-236A+AD-236B)DRUG

AD-236A+AD-236B Oral Tablet

Arm AArm B

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult volunteers aged ≥19 and ≤55 years at the time of the screening visit
  • Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of 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)

H+ Yangji Hospital, Seoul,

Seoul, 08779, South Korea

Location

MeSH Terms

Conditions

HyperlipidemiasDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Central Study Contacts

Heeyoung Hong

CONTACT

821094710619hyhong@addpharma.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

July 29, 2026

Primary Completion (Estimated)

September 13, 2026

Study Completion (Estimated)

September 26, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)