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

March 12, 2026 updated by: Addpharma Inc.

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-118 Compared to AD-1181 in Healthy Adult Volunteers

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • H PLUS YANGJI HOSPITAL, Seoul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A

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
Single-dose oral administration of AD-118 or AD-1181, according to randomized sequence.
Experimental: Sequence B

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
Single-dose oral administration of AD-118 or AD-1181, according to randomized sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time Frame: pre-dose (0hour) to 36hours
AUCt of AD-118
pre-dose (0hour) to 36hours
Maximum concentration of drug in plasma (Cmax)
Time Frame: pre-dose (0hour) to 36hours
Cmax of AD-118
pre-dose (0hour) to 36hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AD-118BE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Heart Failure

Clinical Trials on AD-118, AD-1181

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe