Healthy VolunteersPhase 1NCT06155487
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
A Phase 1 study of Healthy Volunteers and Chronic Pain Syndrome, run by JMackem Co., Ltd at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Chronic Pain Syndrome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Dec 2023to 28 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers, Chronic Pain Syndrome
- Being tested
- AJH-2947 tablets or placebo
- Keywords
- Neuropathic Pain, TRPV1 antagonist, Phase 1
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJH-2947 tablets or placeboDrug
Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | 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. Receives: Drug: AJH-2947 tablets or placebo |
| Part B: Multiple Ascending Dose (MAD) | Experimental | 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. Receives: Drug: AJH-2947 tablets or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (SAD): Maximum observed plasma concentration (Cmax)
To characterize the Cmax of AJH-2947 following a single oral dose under fed or fasted conditions.
Measured: Day 1 to Day 7
Part A (SAD): Area under the concentration-time curve to the last quantifiable concentration (AUClast)
To characterize the AUClast of AJH-2947 following a single oral dose under fed or fasted conditions.
Measured: Day 1 to Day 7
Part A (SAD): Area under the concentration-time curve extrapolated to infinity (AUCinf)
To characterize the AUCinf of AJH-2947 following a single oral dose under fed or fasted conditions.
Measured: Day 1 to Day 7
Part B (MAD): Maximum observed plasma concentration following the first dose (Cmax)
To characterize the maximum observed plasma concentration (Cmax) of AJH-2947 following the first dose.
Measured: Day 1 to Day 2
Part B (MAD): Area under the concentration-time curve over the dosing interval following the first dose (AUCtau)
To characterize the area under the plasma concentration-time curve over the dosing interval following the first oral dose (AUCtau) of AJH-2947.
Measured: Day 1 to Day 2
Part B (MAD): Maximum observed plasma concentration at steady state (Cmax,ss)
To characterize the maximum observed plasma concentration at steady state (Cmax,ss) of AJH-2947 following once-daily oral administration for 7 consecutive days.
Measured: Day 7 to Day 8
Part B (MAD): Area under the concentration-time curve over the dosing interval at steady state (AUCtau,ss)
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.
Measured: Day 7 to Day 8
Number of participants with AEs, SAEs, and clinically significant safety findings
To assess safety and tolerability based on adverse events, vital signs, 12-lead ECGs, clinical laboratory tests, and physical examinations.
Measured: From signing informed consent through the post-study visit (up to Day 18)
Secondary outcomes (2)
Part B (MAD): Heat pain threshold
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.
Measured: Predose (Day -1), Day 1, and Day 7
Part B (MAD): Heat pain tolerance
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.
Measured: Predose (Day -1), Day 1, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start5 Dec 2023
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, double-blind, placebo-controlled, sequential single- and multiple-ascending-dose cohorts.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- JMackem Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Seung-Hwan Lee, MD. Ph.D, Principal investigator, Seoul National University Clinical Trials Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155487
- Sponsor's protocol ID
- AJH-2947_101
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not currently have a plan or an established mechanism to share de-identified individual participant data with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06155487
- Acronym / sponsor ID
- AJH-2947_101
- Conditions
- Healthy Volunteers, Chronic Pain Syndrome
- Keywords
- Neuropathic Pain, TRPV1 antagonist, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- JMackem Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, sequential single- and multiple-ascending-dose cohorts.
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: AJH-2947 tablets or placeboHealthy 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. |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: AJH-2947 tablets or placeboHealthy Korean or Caucasian adult male participants received AJH-2947 or placebo orally once daily for 7 days across three dose cohorts under fed conditions. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AJH-2947 tablets or placeboAdministration: Oral | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Part B (MAD): Heat pain threshold
Time frame: Predose (Day -1), Day 1, and Day 7
Part B (MAD): Heat pain tolerance
Time frame: Predose (Day -1), Day 1, and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. The sponsor does not currently have a plan or an established mechanism to share de-identified individual participant data with external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Hwan Lee, MD. Ph.D principal investigator
Seoul National University Clinical Trials Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy Volunteers and Chronic Pain Syndrome, run by JMackem Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A (SAD): Maximum observed plasma concentration (Cmax) (time frame: Day 1 to Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.