Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males

December 9, 2025 updated by: J2H Biotech

A Dose Block-randomized, Double-blind, Placebo Controlled, Single and Multiple-dosing, Dose-escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, PK/PD of J2H-1702 After Oral Administration in Healthy Male Subjects

  1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
  2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects in all dose groups will be randomized to the study group (J2H-1702 group) and the control group (Placebo group) in a 8:2 ratio. Adverse event (AE) collection, physical examination, vital signs, ECG, clinical laboratory tests, etc. will be performed to assess the safety and tolerability, and blood and urine sampling will be performed to assess the PK/PD characteristics. In addition, blood sampling for mass cytometry (multiple administration study) and baseline fibroscan will be performed for the exploratory evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • South Korea
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16684
        • J2H Biotech

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. A healthy male adult within the range of 19 to 45 years old
  2. BMI=18.0~27.0kg/m2 (Body mass index, BMI)
  3. A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
  4. A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
  5. A subject who has voluntarily agree to participate in the study

Exclusion Criteria:

  1. A subject who had or has the disease corresponding to clinically significant liver, etc.
  2. A subject with a history of gastrointestinal diseases or surgery
  3. A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
  4. A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
  5. One who has drug abuse and one who is positive response in urine drug screening tests
  6. A subject with abnormal vital signs at the screening visit
  7. A subject who has participated in another clinical trial or bioequivalence test
  8. A subject who donated whole blood or the ingredient, or received blood transfusion
  9. A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
  10. A subject who consumes grapefruit/caffeine-containing food
  11. A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
  12. High caffeine intaker, high alcohol intaker or excessive smoker
  13. A subject who cannot eat meals provided by the Clinical Trial institution.
  14. A subject who participated in this trial and were administered the investigational product.
  15. A subject who is positive for serum test
  16. A subject who the investigator deems inappropriate for this clinical trial.

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single administration Amg dose Group
Drug: Single administration Amg dose Group
Orally, Amg tablet single administration
Experimental: Single administration Bmg dose Group
Drug: Single administration Bmg dose Group
Orally, Bmg tablet single administration
Experimental: Single administration Cmg dose Group
Drug: Single administration Cmg dose Group
Orally, Cmg tablet single administration
Experimental: Single administration Dmg dose Group
Drug: Single administration Dmg dose Group
Orally, Dmg tablet single administration
Experimental: Single administration Emg dose Group
Drug: Single administration Emg dose Group
Orally, Emg tablet single administration
Placebo Comparator: Single administration Amg dose Group-Placebo
Drug: Single administration Amg dose Group-Placebo
Orally, Placebo Amg tablet, single administration
Placebo Comparator: Single administration Bmg dose Group-Placebo
Drug: Single administration Bmg dose Group-Placebo
Orally, Placebo Bmg tablet, single administration
Placebo Comparator: Single administration Cmg dose Group-Placebo
Drug: Single administration Cmg dose Group-Placebo
Orally, Placebo Cmg tablet, single administration
Placebo Comparator: Single administration Dmg dose Group-Placebo
Drug: Single administration Dmg dose Group-Placebo
Orally, Placebo Dmg tablet, single administration
Placebo Comparator: Single administration Emg dose Group-Placebo
Drug: Single administration Emg dose Group-Placebo
Orally, Placebo Emg tablet, single administration
Experimental: Multiple administration Amg dose group
Drug: Multiple administration Amg dose group
Orally, Amg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Bmg dose group
Drug: Multiple administration Bmg dose group
Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Cmg dose group
Drug: Multiple administration Cmg dose group
Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Dmg dose group
Drug: Multiple administration Dmg dose group
Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Emg dose group
Drug: Multiple administration Emg dose group
Orally, Emg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Amg dose group - Placebo
Drug: Multiple administration Amg dose group - Placebo
Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Bmg dose group - Placebo
Drug: Multiple administration Bmg dose group - Placebo
Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Cmg dose group - Placebo
Drug: Multiple administration Cmg dose group - Placebo
Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Dmg dose group - Placebo
Drug: Multiple administration Dmg dose group - Placebo
Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Emg dose group - Placebo
Drug: Multiple administration Emg dose group - Placebo
Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours (After IP administration)
Pharmacokinetics
1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours (After IP administration)
Emax
Time Frame: -1day 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours, 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours (After IP administration)
Pharmacodynamics
-1day 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours, 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours (After IP administration)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
J2H Biotech

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JH-201-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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