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

Sponsor
JMackem Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06155487
Collaborator
Seoul National University Hospital (Other)
68
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9
16.1
4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: AJH-2947 100 mg (SAD)
  • Drug: Placebo
  • Drug: AJH-2947 200 mg (SAD)
  • Drug: Placebo
  • Drug: AJH-2947 300 mg (SAD)
  • Drug: Placebo
  • Drug: AJH-2947 400 mg (SAD)
  • Drug: Placebo
  • Drug: AJH-2947 600 mg (SAD)
  • Drug: Placebo
  • Drug: AJH-2947 800 mg (SAD)
  • Drug: Placebo
  • Drug: AJH-2947 200 mg (MAD)
  • Drug: Placebo
  • Drug: AJH-2947 400 mg (MAD)
  • Drug: Placebo
  • Drug: AJH-2947 600 mg (MAD)
  • Drug: Placebo
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized, double-blind, placebo-controlled, single and multiple ascending doseA randomized, double-blind, placebo-controlled, single and multiple ascending dose
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 27, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: (Part A) Single dose group 1

Oral dose of AJH-2947/placebo 100 mg, Korean Only*

Drug: AJH-2947 100 mg (SAD)
Oral Tablet, Single dose of AJH-2947 100 mg

Drug: Placebo
Oral Tablet, Single dose of Placebo 100 mg

Experimental: (Part A) Single dose group 2

Oral dose of AJH-2947/placebo 200 mg, Korean and Caucasian

Drug: AJH-2947 200 mg (SAD)
Oral Tablet, Single dose of AJH-2947 200 mg

Drug: Placebo
Oral Tablet, Single dose of Placebo 200 mg

Experimental: (Part A) Single dose group 3

Oral dose of AJH-2947/placebo 300 mg, Korean and Caucasian

Drug: AJH-2947 300 mg (SAD)
Oral Tablet, Single dose of AJH-2947 300 mg

Drug: Placebo
Oral Tablet, Single dose of Placebo 300 mg

Experimental: (Part A) Single dose group 4

Oral dose of AJH-2947/placebo 400 mg, Korean and Caucasian

Drug: AJH-2947 400 mg (SAD)
Oral Tablet, Single dose of AJH-2947 400 mg

Drug: Placebo
Oral Tablet, Single dose of Placebo 400 mg

Experimental: (Part A) Single dose group 5

Oral dose of AJH-2947/placebo 600 mg, Korean and Caucasian

Drug: AJH-2947 600 mg (SAD)
Oral Tablet, Single dose of AJH-2947 600 mg

Drug: Placebo
Oral Tablet,Single dose of Placebo 600 mg

Experimental: (Part A) Single dose group 6

Oral dose of AJH-2947/placebo 800 mg, Korean and Caucasian

Drug: AJH-2947 800 mg (SAD)
Oral Tablet, Single dose of AJH-2947 800 mg

Drug: Placebo
Oral Tablet, Single dose of Placebo 800 mg

Experimental: (Part B) Multiple dose group 1

Oral dose of AJH-2947/placebo 200 mg, Korean and Caucasian

Drug: AJH-2947 200 mg (MAD)
Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 200 mg

Drug: Placebo
Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg

Experimental: (Part B) Multiple dose group 2

Oral dose of AJH-2947/placebo 400 mg, Korean and Caucasian

Drug: AJH-2947 400 mg (MAD)
Oral Tablet,Multiple (once daily for 7days) oral dose of AJH-2947 400 mg

Drug: Placebo
Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg

Experimental: (Part B) Multiple dose group 3

Oral dose of AJH-2947/placebo 600 mg, Korean and Caucasian

Drug: AJH-2947 600 mg (MAD)
Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 600 mg

Drug: Placebo
Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg

Outcome Measures

Primary Outcome Measures

  1. Part A (SAD): Plasma concentrations of AJH-2947 [Day 1 to Day 5]

    To characterize the plasma concentration of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.

  2. Part A (SAD): Urine concentrations of AJH-2947 [Day 1 to Day 4]

    To characterize the urine concentration of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.

  3. Part A (SAD): Maximum observed concentration [Cmax] [Day 1 to Day 5]

    To characterize the Cmax of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants

  4. Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration [AUClast] [Day 1 to Day 5]

    To characterize the AUClast of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.

  5. Part A (SAD): Time to reach peak or maximum observed concentration [Tmax] [Day 1 to Day 5]

    To characterize the Tmax of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.

  6. Part B (MAD): Plasma concentrations of AJH-2947 [Day 1 to Day 18]

    To characterize the plasma concentration of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  7. Part B (MAD): Maximum observed concentration [Cmax] [Day 1 to Day 18]

    To characterize the Cmax of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  8. Part B (MAD): The partial area from dosing time to dosing time plus dosing interval [AUCτ] [Day 1 to Day 18]

    To characterize the AUCτ of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  9. Part B (MAD): Time of maximum observed concentration [Tmax] [Day 1 to Day 18]

    To characterize the Tmax of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  10. Part B (MAD): Maximum observed concentration occurring at time Tmax,ss [Cmax,ss] [Day 1 to Day 18]

    To characterize the Cmax,ss of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  11. Part B (MAD): At steady state, the partial area from dosing time to dosing time plus dosing interval [AUCτ,ss] [Day 1 to Day 18]

    To characterize the AUCτ,ss of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  12. Part B (MAD): Heat pain Threshold (The temperature at which the subject first perceives pain, ℃) [Predose, Day 1, Day 7, and Day 8]

    Heat pain Threshold is determined by gradually increased the temperature of the thermal probe on non-sensitized and casaicin-sensitized skin starting from 30 ℃ as the baseline using Thermal NeuroSensory Analyzer. (The cutoff limit is set at 50°C)

  13. Part B (MAD): Heat pain tolerance (The Maximum temperature that the subject can tolerate, ℃) [Predose, Day 1, Day 7, and Day 8]

    Heat pain tolerance is determined by gradually increased the temperature of the thermal probe on non-sensitized and casaicin-sensitized skin starting from 30 ℃ as the baseline using Thermal NeuroSensory Analyzer. (The cutoff limit is set at 50°C)

Secondary Outcome Measures

  1. Part A (SAD): Number of participants with adverse events (AE) [Day -1, Day 1 to day 12 (last visit)]

    To assess the safety and tolerability of AJH-2947 following oral administration of single ascending doses in healthy Korean and Caucasian male participants.

  2. Part A (SAD): Number of participants with serious adverse events (SAE) [Day -1, Day 1 to day 18 (last visit)]

    To assess the safety and tolerability of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  3. Part B (MAD): Number of participants with AE [Day -1, Day 1 to day 18 (last visit)]

    To assess the safety and tolerability of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

  4. Part B (MAD): Number of participants with SAE [Day -1, Day 1 to day 18 (last visit)]

    To assess the safety and tolerability of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Healthy Korean or Caucasian adult males aged 19 to 55 years old, based on the date of written consent

*Caucasian subjects = Individuals born in Europe, have resided in countries outside Europe for less than 10 years, and whose parents and grandparents are all of European descent.

  1. 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
  • BMI (kg/m2) = weight (kg) / {height (m)}2
  1. 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)

  2. 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

  3. 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:
  1. Individuals with clinically significant diseases or a history of diseases related to the liver, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, blood/tumors, cardiovascular system, urinary system, mental disorders, etc.

  2. In the multiple-dose trial, individuals with skin lesions, tattoos on both forearms or show hypersensitivity or allergic reactions to capsaicin cream who may affect the pharmacodynamic evaluation of the investigational product.

  3. Individuals with gastrointestinal diseases (such as gastrointestinal ulcers, gastritis, gastric spasm, gastroesophageal reflux disease, and Crohn's disease) or a history of surgery that may affect the safety and pharmacokinetic evaluation of the investigational product (excluding simple appendectomy and hernia repair)

  4. Individuals with a medical history of hypersensitivity reactions to the main active ingredient or components of the investigational product or to drugs in the same class as the main active ingredient

  5. Individuals with positive results for hepatitis B (HBV) test, hepatitis C (HCV) test, syphilis (RPR) test, or HIV test conducted during screening

  6. Individuals who exhibited systolic blood pressure < 80 mmHg or ≥ 140 mmHg or diastolic blood pressure < 45 mmHg or ≥ 90 mmHg during vital sign measurements in the supine position after a rest period of at least three minutes

  7. Individuals with a history of drug abuse or who tested positive for drug abuse in the urine drug screening test

  8. Individuals who have taken prescription drugs or traditional herbal medicine within 2 weeks before the scheduled first dose of the investigational product or have taken any over-the-counter medicines, health-functional foods, or vitamin supplements within 1 week, or are expected to take them

  9. Individuals who have participated in another clinical trial (including bioequivalence studies) within 6 months before the scheduled first dose of the investigational product

  10. Individuals who donated blood within 2 months or donated blood components within 1 month, or received a blood transfusion within 1 month before the scheduled first dose of the investigational product

  11. Individuals who have consumed excessive caffeine (> 5 units/day) or cannot abstain from consuming caffeine/caffeine-containing foods (such as coffee, tea, carbonated beverages, coffee-flavored milk, energy drinks, etc.) from 3 days before the expected first dose until the end of the clinical trial (PSV)

  12. Individuals who engage in persistent alcohol consumption (> 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol consumption from 3 days before the expected first dose of the investigational product until the end of the clinical trial (PSV) (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g, 1 glass (125 mL) of wine (12%) = 12 g)

  13. Individuals who have smoked more than 10 cigarettes/day within the last 3 months before the scheduled first dose of the investigational product or cannot quit smoking from the screening day until the end of the clinical trial (PSV)

  14. Individuals who cannot refrain from consuming grapefruit-containing foods from 3 days before the expected first dose of the investigational product until the end of the clinical trial (PSV)

  15. Individuals who have a pregnancy planning during the entire clinical trial and up to 90 days after the last administration of the investigational product or do not agree to use one or more medically acceptable contraceptive methods. The medically acceptable contraceptive methods are as follows:

① Use of an intrauterine device with a proven failure rate by the spouse (or partner)

② Concurrent use of barrier contraception (male or female) and oral contraceptive pills

③ Self or partner's surgical sterilization (vasectomy, salpingectomy / tubal ligation, hysterectomy)

  1. Individuals deemed ineligible for participation in the clinical trial by the investigator based on other reasons, including results of clinical laboratory tests

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • JMackem Co., Ltd
  • Seoul National University Hospital

Investigators

  • Principal Investigator: Seung-Hwan Lee, MD. Ph.D, Seoul National University Clinical Trails Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JMackem Co., Ltd
ClinicalTrials.gov Identifier:
NCT06155487
Other Study ID Numbers:
  • AJH-2947_101
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by JMackem Co., Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023