By InvitationPhase 1

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

South Korea68 participantsStarted 2023-12-05

Plain-language summary

Preliminary evaluate of pharmacokinetics, pharmacodynamics, safety and tolerability after oral administration of AJH-2947 in healthy Korean or Caucasian male subjects

Who can participate

Age range

19 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy Korean or Caucasian adult males aged 19 to 55 years old, based on the date of written consent
. Individuals with a body weight between 50.0 kg and 90.0 kg and a body mass index (BMI) ranging from 18.5 kg/m2 to less than 30.0 kg/m2
. Individuals who agree to stay in the CTC ward until discharge and consent to the use of sunscreen until the end of the clinical trial (PSV)
. Individuals who have heard a detailed explanation of the trial, fully understand it, voluntarily decide to participate, and provide written consent before the screening examination
. Individuals deemed suitable by the investigator based on medical history, vital signs, 12-lead electrocardiogram (ECG), physical examination, and clinical laboratory tests performed during the screening.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A (SAD): Plasma concentrations of AJH-2947

Timeframe: Day 1 to Day 5

Part A (SAD): Urine concentrations of AJH-2947

Timeframe: Day 1 to Day 4

Part A (SAD): Maximum observed concentration [Cmax]

Timeframe: Day 1 to Day 5

Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration [AUClast]

Timeframe: Day 1 to Day 5

Part A (SAD): Time to reach peak or maximum observed concentration [Tmax]

Timeframe: Day 1 to Day 5

Part B (MAD): Plasma concentrations of AJH-2947

Timeframe: Day 1 to Day 18

Part B (MAD): Maximum observed concentration [Cmax]

Timeframe: Day 1 to Day 18

Trial details

NCT IDNCT06155487

SponsorJMackem Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04

View on ClinicalTrials.gov More Neuropathic Pain trials

Who can participate

Age range

19 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy Korean or Caucasian adult males aged 19 to 55 years old, based on the date of written consent
. Individuals with a body weight between 50.0 kg and 90.0 kg and a body mass index (BMI) ranging from 18.5 kg/m2 to less than 30.0 kg/m2
. Individuals who agree to stay in the CTC ward until discharge and consent to the use of sunscreen until the end of the clinical trial (PSV)
. Individuals who have heard a detailed explanation of the trial, fully understand it, voluntarily decide to participate, and provide written consent before the screening examination
. Individuals deemed suitable by the investigator based on medical history, vital signs, 12-lead electrocardiogram (ECG), physical examination, and clinical laboratory tests performed during the screening.

Exclusion criteria

What they're measuring

Part A (SAD): Plasma concentrations of AJH-2947

Timeframe: Day 1 to Day 5

Part A (SAD): Urine concentrations of AJH-2947

Timeframe: Day 1 to Day 4

Part A (SAD): Maximum observed concentration [Cmax]

Timeframe: Day 1 to Day 5

Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration [AUClast]

Timeframe: Day 1 to Day 5

Part A (SAD): Time to reach peak or maximum observed concentration [Tmax]

Timeframe: Day 1 to Day 5

Part B (MAD): Plasma concentrations of AJH-2947

Timeframe: Day 1 to Day 18

Part B (MAD): Maximum observed concentration [Cmax]

Timeframe: Day 1 to Day 18