Non-alcoholic SteatohepatitisPhase 1NCT06308861
Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males
A Phase 1 study testing Single administration Amg dose Group, Single administration Bmg dose Group and Single administration Cmg dose Group in people with Non-alcoholic Steatohepatitis, run by J2H Biotech at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- Single administration Amg dose Group, Single administration Bmg dose Group and Single administration Cmg dose Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2020to 13 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy male adult within the range of 19 to 45 years old
- BMI=18.0~27.0kg/m2 (Body mass index, BMI)
- A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
- A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
- A subject who has voluntarily agree to participate in the study
Who cannot join
- A subject who had or has the disease corresponding to clinically significant liver, etc.
- A subject with a history of gastrointestinal diseases or surgery
- A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
- A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
- One who has drug abuse and one who is positive response in urine drug screening tests
- A subject with abnormal vital signs at the screening visit
Show all 16Show fewer
- A subject who has participated in another clinical trial or bioequivalence test
- A subject who donated whole blood or the ingredient, or received blood transfusion
- A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
- A subject who consumes grapefruit/caffeine-containing food
- A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
- High caffeine intaker, high alcohol intaker or excessive smoker
- A subject who cannot eat meals provided by the Clinical Trial institution.
- A subject who participated in this trial and were administered the investigational product.
- A subject who is positive for serum test
- A subject who the investigator deems inappropriate for this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
- Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial
Read the 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.
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- Single administration Amg dose Group, Single administration Bmg dose Group, Single administration Cmg dose Group, Single administration Dmg dose Group, Single administration Emg dose Group
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single administration Amg dose GroupDrug
Orally, Amg tablet single administration
Single administration Bmg dose GroupDrug
Orally, Bmg tablet single administration
Single administration Cmg dose GroupDrug
Orally, Cmg tablet single administration
Single administration Dmg dose GroupDrug
Orally, Dmg tablet single administration
Single administration Emg dose GroupDrug
Orally, Emg tablet single administration
Single administration Amg dose Group-PlaceboDrug
Orally, Placebo Amg tablet, single administration
Single administration Bmg dose Group-PlaceboDrug
Orally, Placebo Bmg tablet, single administration
Single administration Cmg dose Group-PlaceboDrug
Orally, Placebo Cmg tablet, single administration
Single administration Dmg dose Group-PlaceboDrug
Orally, Placebo Dmg tablet, single administration
Single administration Emg dose Group-PlaceboDrug
Orally, Placebo Emg tablet, single administration
Multiple administration Amg dose groupDrug
Orally, Amg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Bmg dose groupDrug
Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Cmg dose groupDrug
Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Dmg dose groupDrug
Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Emg dose groupDrug
Orally, Emg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Amg dose group - PlaceboDrug
Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Bmg dose group - PlaceboDrug
Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Cmg dose group - PlaceboDrug
Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Dmg dose group - PlaceboDrug
Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
Multiple administration Emg dose group - PlaceboDrug
Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration
| Study group | Role | What they receive |
|---|---|---|
| Single administration Amg dose Group | Experimental | Not described Receives: Drug: Single administration Amg dose Group |
| Single administration Bmg dose Group | Experimental | Not described Receives: Drug: Single administration Bmg dose Group |
| Single administration Cmg dose Group | Experimental | Not described Receives: Drug: Single administration Cmg dose Group |
| Single administration Dmg dose Group | Experimental | Not described Receives: Drug: Single administration Dmg dose Group |
| Single administration Emg dose Group | Experimental | Not described Receives: Drug: Single administration Emg dose Group |
| Single administration Amg dose Group-Placebo | Placebo comparator | Not described Receives: Drug: Single administration Amg dose Group-Placebo |
| Single administration Bmg dose Group-Placebo | Placebo comparator | Not described Receives: Drug: Single administration Bmg dose Group-Placebo |
| Single administration Cmg dose Group-Placebo | Placebo comparator | Not described Receives: Drug: Single administration Cmg dose Group-Placebo |
| Single administration Dmg dose Group-Placebo | Placebo comparator | Not described Receives: Drug: Single administration Dmg dose Group-Placebo |
| Single administration Emg dose Group-Placebo | Placebo comparator | Not described Receives: Drug: Single administration Emg dose Group-Placebo |
| Multiple administration Amg dose group | Experimental | Not described Receives: Drug: Multiple administration Amg dose group |
| Multiple administration Bmg dose group | Experimental | Not described Receives: Drug: Multiple administration Bmg dose group |
| Multiple administration Cmg dose group | Experimental | Not described Receives: Drug: Multiple administration Cmg dose group |
| Multiple administration Dmg dose group | Experimental | Not described Receives: Drug: Multiple administration Dmg dose group |
| Multiple administration Emg dose group | Experimental | Not described Receives: Drug: Multiple administration Emg dose group |
| Multiple administration Amg dose group - Placebo | Placebo comparator | Not described Receives: Drug: Multiple administration Amg dose group - Placebo |
| Multiple administration Bmg dose group - Placebo | Placebo comparator | Not described Receives: Drug: Multiple administration Bmg dose group - Placebo |
| Multiple administration Cmg dose group - Placebo | Placebo comparator | Not described Receives: Drug: Multiple administration Cmg dose group - Placebo |
| Multiple administration Dmg dose group - Placebo | Placebo comparator | Not described Receives: Drug: Multiple administration Dmg dose group - Placebo |
| Multiple administration Emg dose group - Placebo | Placebo comparator | Not described Receives: Drug: Multiple administration Emg dose group - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics
Measured: 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
Pharmacodynamics
Measured: -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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start12 Aug 2020
- Primary completion25 Jun 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- J2H Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308861
- Sponsor's protocol ID
- JH-201-101
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06308861
- Acronym / sponsor ID
- JH-201-101
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- J2H BiotechIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
- Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Single administration Amg dose Group | Experimental | Drug: Single administration Amg dose Group |
| Single administration Bmg dose Group | Experimental | Drug: Single administration Bmg dose Group |
| Single administration Cmg dose Group | Experimental | Drug: Single administration Cmg dose Group |
| Single administration Dmg dose Group | Experimental | Drug: Single administration Dmg dose Group |
| Single administration Emg dose Group | Experimental | Drug: Single administration Emg dose Group |
| Single administration Amg dose Group-Placebo | Placebo comparator | Drug: Single administration Amg dose Group-Placebo |
| Single administration Bmg dose Group-Placebo | Placebo comparator | Drug: Single administration Bmg dose Group-Placebo |
| Single administration Cmg dose Group-Placebo | Placebo comparator | Drug: Single administration Cmg dose Group-Placebo |
| Single administration Dmg dose Group-Placebo | Placebo comparator | Drug: Single administration Dmg dose Group-Placebo |
| Single administration Emg dose Group-Placebo | Placebo comparator | Drug: Single administration Emg dose Group-Placebo |
| Multiple administration Amg dose group | Experimental | Drug: Multiple administration Amg dose group |
| Multiple administration Bmg dose group | Experimental | Drug: Multiple administration Bmg dose group |
| Multiple administration Cmg dose group | Experimental | Drug: Multiple administration Cmg dose group |
| Multiple administration Dmg dose group | Experimental | Drug: Multiple administration Dmg dose group |
| Multiple administration Emg dose group | Experimental | Drug: Multiple administration Emg dose group |
| Multiple administration Amg dose group - Placebo | Placebo comparator | Drug: Multiple administration Amg dose group - Placebo |
| Multiple administration Bmg dose group - Placebo | Placebo comparator | Drug: Multiple administration Bmg dose group - Placebo |
| Multiple administration Cmg dose group - Placebo | Placebo comparator | Drug: Multiple administration Cmg dose group - Placebo |
| Multiple administration Dmg dose group - Placebo | Placebo comparator | Drug: Multiple administration Dmg dose group - Placebo |
| Multiple administration Emg dose group - Placebo | Placebo comparator | Drug: Multiple administration Emg dose group - Placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy male adult within the range of 19 to 45 years old
- BMI=18.0~27.0kg/m2 (Body mass index, BMI)
- A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
- A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
- A subject who has voluntarily agree to participate in the study
Key exclusion criteria (16 listed)
- A subject who had or has the disease corresponding to clinically significant liver, etc.
- A subject with a history of gastrointestinal diseases or surgery
- A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
- A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
- One who has drug abuse and one who is positive response in urine drug screening tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single administration Amg dose GroupOrally, Amg tablet single administration | Drug | Single administration Amg dose Group |
| Single administration Bmg dose GroupOrally, Bmg tablet single administration | Drug | Single administration Bmg dose Group |
| Single administration Cmg dose GroupOrally, Cmg tablet single administration | Drug | Single administration Cmg dose Group |
| Single administration Dmg dose GroupOrally, Dmg tablet single administration | Drug | Single administration Dmg dose Group |
| Single administration Emg dose GroupOrally, Emg tablet single administration | Drug | Single administration Emg dose Group |
| Single administration Amg dose Group-PlaceboOrally, Placebo Amg tablet, single administration | Drug | Single administration Amg dose Group-Placebo |
| Single administration Bmg dose Group-PlaceboOrally, Placebo Bmg tablet, single administration | Drug | Single administration Bmg dose Group-Placebo |
| Single administration Cmg dose Group-PlaceboOrally, Placebo Cmg tablet, single administration | Drug | Single administration Cmg dose Group-Placebo |
| Single administration Dmg dose Group-PlaceboOrally, Placebo Dmg tablet, single administration | Drug | Single administration Dmg dose Group-Placebo |
| Single administration Emg dose Group-PlaceboOrally, Placebo Emg tablet, single administration | Drug | Single administration Emg dose Group-Placebo |
| Multiple administration Amg dose groupOrally, Amg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Amg dose group |
| Multiple administration Bmg dose groupOrally, Bmg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Bmg dose group |
| Multiple administration Cmg dose groupOrally, Cmg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Cmg dose group |
| Multiple administration Dmg dose groupOrally, Dmg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Dmg dose group |
| Multiple administration Emg dose groupOrally, Emg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Emg dose group |
| Multiple administration Amg dose group - PlaceboOrally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Amg dose group - Placebo |
| Multiple administration Bmg dose group - PlaceboOrally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Bmg dose group - Placebo |
| Multiple administration Cmg dose group - PlaceboOrally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Cmg dose group - Placebo |
| Multiple administration Dmg dose group - PlaceboOrally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Dmg dose group - Placebo |
| Multiple administration Emg dose group - PlaceboOrally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration | Drug | Multiple administration Emg dose group - Placebo |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single administration Amg dose Group, Single administration Bmg dose Group and Single administration Cmg dose Group in people with Non-alcoholic Steatohepatitis, run by J2H Biotech at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.