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

NCT06155487 | Completed Phase 1

• 1 other identifier: AJH-2947_101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Chronic Pain Syndrome

Keywords

Neuropathic Pain; TRPV1 antagonist; Phase 1

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From signing informed consent through the post-study visit (up to Day 18)

Secondary Outcomes (2)

• Part B (MAD): Heat pain threshold

  Predose (Day -1), Day 1, and Day 7

• Part B (MAD): Heat pain tolerance

  Predose (Day -1), Day 1, and Day 7

Study Arms (2)

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.

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.

Drug: AJH-2947 tablets or placebo

Interventions

AJH-2947 tablets or placebo DRUG

Administration: Oral

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JMackem Co., Ltd: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seung-Hwan Lee, MD. Ph.D

  Seoul National University Clinical Trials Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, sequential single- and multiple-ascending-dose cohorts.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 4, 2023
• Study Start: December 5, 2023
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)