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

November 22, 2023 updated by: JMackem Co., Ltd

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

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

Study Overview

Study Type

Interventional

Enrollment (Estimated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jihyae Ann, Ph.D
Phone Number: 82-2-883-9172
Email: jhann@jmackem.com

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      Jihyae Ann, Ph.D
      
      Phone Number: 82-2-883-9172
      
      Email: jhann@jmackem.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.
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
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:

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.
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.
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)
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
Individuals with positive results for hepatitis B (HBV) test, hepatitis C (HCV) test, syphilis (RPR) test, or HIV test conducted during screening
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
Individuals with a history of drug abuse or who tested positive for drug abuse in the urine drug screening test
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
Individuals who have participated in another clinical trial (including bioequivalence studies) within 6 months before the scheduled first dose of the investigational product
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
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)
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)
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)
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)
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)
Individuals deemed ineligible for participation in the clinical trial by the investigator based on other reasons, including results of clinical laboratory tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / 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 Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg
Experimental: (Part A) Single dose group 2 Oral dose of AJH-2947/placebo 200 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 200 mg (SAD) Oral Tablet, Single dose of AJH-2947 200 mg
Experimental: (Part A) Single dose group 3 Oral dose of AJH-2947/placebo 300 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 300 mg (SAD) Oral Tablet, Single dose of AJH-2947 300 mg
Experimental: (Part A) Single dose group 4 Oral dose of AJH-2947/placebo 400 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 400 mg (SAD) Oral Tablet, Single dose of AJH-2947 400 mg
Experimental: (Part A) Single dose group 5 Oral dose of AJH-2947/placebo 600 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 600 mg (SAD) Oral Tablet, Single dose of AJH-2947 600 mg
Experimental: (Part A) Single dose group 6 Oral dose of AJH-2947/placebo 800 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 800 mg (SAD) Oral Tablet, Single dose of AJH-2947 800 mg
Experimental: (Part B) Multiple dose group 1 Oral dose of AJH-2947/placebo 200 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 200 mg (MAD) Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 200 mg
Experimental: (Part B) Multiple dose group 2 Oral dose of AJH-2947/placebo 400 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 400 mg (MAD) Oral Tablet,Multiple (once daily for 7days) oral dose of AJH-2947 400 mg
Experimental: (Part B) Multiple dose group 3 Oral dose of AJH-2947/placebo 600 mg, Korean and Caucasian	Drug: Placebo Oral Tablet, Single dose of Placebo 100 mg Drug: Placebo Oral Tablet, Single dose of Placebo 200 mg Drug: Placebo Oral Tablet, Single dose of Placebo 300 mg Drug: Placebo Oral Tablet, Single dose of Placebo 400 mg Drug: Placebo Oral Tablet,Single dose of Placebo 600 mg Drug: Placebo Oral Tablet, Single dose of Placebo 800 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg Drug: Placebo Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg Drug: AJH-2947 600 mg (MAD) Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A (SAD): Plasma concentrations of AJH-2947 Time Frame: Day 1 to Day 5	To characterize the plasma concentration of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.	Day 1 to Day 5
Part A (SAD): Urine concentrations of AJH-2947 Time Frame: Day 1 to Day 4	To characterize the urine concentration of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.	Day 1 to Day 4
Part A (SAD): Maximum observed concentration [Cmax] Time Frame: Day 1 to Day 5	To characterize the Cmax of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants	Day 1 to Day 5
Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration [AUClast] Time Frame: Day 1 to Day 5	To characterize the AUClast of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.	Day 1 to Day 5
Part A (SAD): Time to reach peak or maximum observed concentration [Tmax] Time Frame: Day 1 to Day 5	To characterize the Tmax of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.	Day 1 to Day 5
Part B (MAD): Plasma concentrations of AJH-2947 Time Frame: 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.	Day 1 to Day 18
Part B (MAD): Maximum observed concentration [Cmax] Time Frame: 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.	Day 1 to Day 18
Part B (MAD): The partial area from dosing time to dosing time plus dosing interval [AUCτ] Time Frame: 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.	Day 1 to Day 18
Part B (MAD): Time of maximum observed concentration [Tmax] Time Frame: 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.	Day 1 to Day 18
Part B (MAD): Maximum observed concentration occurring at time Tmax,ss [Cmax,ss] Time Frame: 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.	Day 1 to Day 18
Part B (MAD): At steady state, the partial area from dosing time to dosing time plus dosing interval [AUCτ,ss] Time Frame: 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.	Day 1 to Day 18
Part B (MAD): Heat pain Threshold (The temperature at which the subject first perceives pain, ℃) Time Frame: 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)	Predose, Day 1, Day 7, and Day 8
Part B (MAD): Heat pain tolerance (The Maximum temperature that the subject can tolerate, ℃) Time Frame: 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)	Predose, Day 1, Day 7, and Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A (SAD): Number of participants with adverse events (AE) Time Frame: 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.	Day -1, Day 1 to day 12 (last visit)
Part A (SAD): Number of participants with serious adverse events (SAE) Time Frame: 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.	Day -1, Day 1 to day 18 (last visit)
Part B (MAD): Number of participants with AE Time Frame: 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.	Day -1, Day 1 to day 18 (last visit)
Part B (MAD): Number of participants with SAE Time Frame: 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.	Day -1, Day 1 to day 18 (last visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JMackem Co., Ltd

Collaborators

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 27, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Estimated)

December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AJH-2947_101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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