A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects

August 11, 2026 updated by: JMackem Co., Ltd

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability After Oral Administration of AJH-2947 in Healthy Korean or Caucasian Male Subjects

The purpose of this randomized, double-blind, placebo-controlled Phase 1 study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of AJH-2947 in healthy Korean or Caucasian adult male participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy Korean or Caucasian adult males aged 19 to 55 years at the time of written informed consent. Caucasian participants were defined as individuals born in Europe who had resided outside Europe for less than 10 years and whose parents and grandparents were all of European descent.

Body weight between 50.0 kg and 90.0 kg and body mass index (BMI) from 18.5 kg/m² to less than 30.0 kg/m².

Willingness to remain in the Clinical Trial Center (CTC) until discharge and to use sunscreen until the end of the study, including the post-study visit (PSV).

Ability to understand the study after receiving a detailed explanation, voluntary agreement to participate, and provision of written informed consent before any screening examination.

Considered suitable for participation by the investigator based on medical history, vital signs, 12-lead electrocardiogram (ECG), physical examination, and clinical laboratory test results obtained during screening.

Exclusion Criteria:

Clinically significant disease or a history of disease involving the liver, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, hematologic system, cardiovascular system, urinary system, psychiatric system, or other clinically relevant body system.

For the multiple-dose trial, skin lesions or tattoos on both forearms, or hypersensitivity or allergic reactions to capsaicin cream that could affect pharmacodynamic evaluation.

Gastrointestinal disease, including gastrointestinal ulcer, gastritis, gastric spasm, gastroesophageal reflux disease, or Crohn's disease, or a history of surgery that could affect the safety or pharmacokinetic evaluation of the investigational product, except for simple appendectomy or hernia repair.

History of hypersensitivity to the active ingredient or other components of the investigational product, or to drugs of the same class.

Positive screening result for hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis (RPR), or human immunodeficiency virus (HIV).

Supine systolic blood pressure below 80 mmHg or at least 140 mmHg, or diastolic blood pressure below 45 mmHg or at least 90 mmHg, measured after at least 3 minutes of rest.

History of drug abuse or a positive urine drug screening result.

Use of prescription medication or traditional herbal medicine within 2 weeks before the scheduled first dose, or use of over-the-counter medication, health-functional food, or vitamin supplements within 1 week before the scheduled first dose, or anticipated use of any such product during the study.

Participation in another clinical trial, including a bioequivalence study, within 6 months before the scheduled first dose.

Donation of whole blood within 2 months, donation of blood components within 1 month, or receipt of a blood transfusion within 1 month before the scheduled first dose.

Excessive caffeine consumption of more than 5 units per day or inability to abstain from caffeine or caffeine-containing foods and beverages from 3 days before the expected first dose until the end of the study, including the PSV.

Persistent alcohol consumption of more than 21 units per week, with 1 unit defined as 10 g of pure alcohol, or inability to abstain from alcohol from 3 days before the expected first dose until the end of the study, including the PSV.

Smoking more than 10 cigarettes per day within the 3 months before the scheduled first dose or inability to stop smoking from screening until the end of the study, including the PSV.

Inability to refrain from consuming grapefruit-containing foods from 3 days before the expected first dose until the end of the study, including the PSV.

Planning a pregnancy during the study or within 90 days after the last administration of the investigational product, or unwillingness to use at least one medically acceptable contraceptive method. Acceptable methods included use of an intrauterine device with a proven failure rate by the participant's spouse or partner; concurrent use of barrier contraception and oral contraceptive pills; or surgical sterilization of the participant or partner, including vasectomy, salpingectomy, tubal ligation, or hysterectomy.

Considered unsuitable for participation by the investigator for any other reason, including clinical laboratory test results.

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: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: Single Ascending Dose (SAD)
Healthy Korean or Caucasian adult male participants received a single oral dose of AJH-2947 or placebo across seven dose cohorts under fasted or fed conditions.
Drug: AJH-2947 tablets or placebo
Administration: Oral
Experimental: Part B: Multiple Ascending Dose (MAD)
Healthy Korean or Caucasian adult male participants received AJH-2947 or placebo orally once daily for 7 days across three dose cohorts under fed conditions.
Drug: AJH-2947 tablets or placebo
Administration: Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A (SAD): Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 to Day 7
To characterize the Cmax of AJH-2947 following a single oral dose under fed or fasted conditions.
Day 1 to Day 7
Part A (SAD): Area under the concentration-time curve to the last quantifiable concentration (AUClast)
Time Frame: Day 1 to Day 7
To characterize the AUClast of AJH-2947 following a single oral dose under fed or fasted conditions.
Day 1 to Day 7
Part A (SAD): Area under the concentration-time curve extrapolated to infinity (AUCinf)
Time Frame: Day 1 to Day 7
To characterize the AUCinf of AJH-2947 following a single oral dose under fed or fasted conditions.
Day 1 to Day 7
Part B (MAD): Maximum observed plasma concentration following the first dose (Cmax)
Time Frame: Day 1 to Day 2
To characterize the maximum observed plasma concentration (Cmax) of AJH-2947 following the first dose.
Day 1 to Day 2
Part B (MAD): Area under the concentration-time curve over the dosing interval following the first dose (AUCtau)
Time Frame: Day 1 to Day 2
To characterize the area under the plasma concentration-time curve over the dosing interval following the first oral dose (AUCtau) of AJH-2947.
Day 1 to Day 2
Part B (MAD): Maximum observed plasma concentration at steady state (Cmax,ss)
Time Frame: Day 7 to Day 8
To characterize the maximum observed plasma concentration at steady state (Cmax,ss) of AJH-2947 following once-daily oral administration for 7 consecutive days.
Day 7 to Day 8
Part B (MAD): Area under the concentration-time curve over the dosing interval at steady state (AUCtau,ss)
Time Frame: Day 7 to Day 8
To characterize the area under the plasma concentration-time curve over the dosing interval at steady state (AUCtau,ss) of AJH-2947 following once-daily oral administration for 7 consecutive days.
Day 7 to Day 8
Number of participants with AEs, SAEs, and clinically significant safety findings
Time Frame: From signing informed consent through the post-study visit (up to Day 18)
To assess safety and tolerability based on adverse events, vital signs, 12-lead ECGs, clinical laboratory tests, and physical examinations.
From signing informed consent through the post-study visit (up to Day 18)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part B (MAD): Heat pain threshold
Time Frame: Predose (Day -1), Day 1, and Day 7
Heat pain threshold was defined as the temperature at which the participant first perceived pain during thermal stimulation of non-sensitized and capsaicin-sensitized skin. The cutoff temperature was 50°C.
Predose (Day -1), Day 1, and Day 7
Part B (MAD): Heat pain tolerance
Time Frame: Predose (Day -1), Day 1, and Day 7
Heat pain tolerance was defined as the maximum temperature that the participant could tolerate during thermal stimulation of non-sensitized and capsaicin-sensitized skin. The cutoff temperature was 50°C.
Predose (Day -1), Day 1, and Day 7

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JMackem Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Hwan Lee, MD. Ph.D, Seoul National University Clinical Trials Center

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AJH-2947_101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The sponsor does not currently have a plan or an established mechanism to share de-identified individual participant data with external researchers.

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.

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