NCT07476157

Brief Summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects

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
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 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

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month 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

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 12, 2026

Last Update Submit

March 12, 2026

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

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

    AUCt of AD-118

    pre-dose (0hour) to 36hours

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-118

    pre-dose (0hour) to 36hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1 : Reference drug(AD-1181), Period 2 : Test drug(AD-118) Single-dose oral administration of AD-1181 in Period 1, followed by single-dose oral administration of AD-118 in Period 2.

Drug: AD-118, AD-1181

Sequence B

EXPERIMENTAL

Period 1 : Test drug(AD-118), Period 2 : Reference drug(AD-1181) Single-dose oral administration of AD-118 in Period 1, followed by single-dose oral administration of AD-1181 in Period 2.

Drug: AD-118, AD-1181

Interventions

AD-118, AD-1181DRUG

Single-dose oral administration of AD-118 or AD-1181, 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 weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 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)

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

Location

Central Study Contacts

JaeHun Jung

CONTACT

+82-31-891-5683jhjung@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

March 12, 2026

First Posted

March 17, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)