NCT07312799

Brief Summary

To evaluate the pharmacokinetic interactions of AD-2321, AD-2322 in healthy adult volunteers.

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
41

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_1 hypertension

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

December 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

15 days

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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 on Day 14

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

    pre-dose (0hour) to 24 hours post-dose on Day 14

Study Arms (2)

Arm A

EXPERIMENTAL

Period 1 : Treatment A(AD-2321), Period 2 : Treatment C(AD-2321+AD-2322)

Drug: Treatment A(AD-2321)Drug: Treatment C(AD-2321+AD-2322)

Arm B

EXPERIMENTAL

Period 1 : Treatment B(AD-2322), Period 2 : Treatment C(AD-2321+AD-2322)

Drug: Treatment B(AD-2322)Drug: Treatment C(AD-2321+AD-2322)

Interventions

Treatment A(AD-2321)DRUG

AD-2321 Oral Tablet

Arm A
Treatment B(AD-2322)DRUG

AD-2322 Oral Tablet

Arm B
Treatment C(AD-2321+AD-2322)DRUG

AD-2321 Oral Tablet+AD-2322 Oral Tablet

Arm AArm B

Eligibility Criteria

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

You may qualify if:

  • Healthy adult volunteers aged ≥19 and \<65 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, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

SoonKeun Kwon

CONTACT

+82318916915skkwon@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

December 17, 2025

First Posted

December 31, 2025

Study Start

January 27, 2026

Primary Completion

February 11, 2026

Study Completion

February 26, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)