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
CompletedPhase 1NCT06155487
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Healthy Volunteers
- Chronic Pain Syndrome
- Interventions
- Drug: AJH-2947 tablets or placebo
- Sponsor
- JMackem Co., Ltd
- Collaborators
- Seoul National University Hospital
- Start date
- 2023-12-05
- Primary completion
- 2026-04-28
- Sex
- Male
- Age range
- from 19 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- South Korea
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 sche…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06155487