Non-alcoholic SteatohepatitisPhase 1NCT06308874
Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females
A Phase 1 study testing Amg dose administration group and Bmg dose administration group in people with Non-alcoholic Steatohepatitis, run by J2H Biotech at 1 site in South Korea.
Trial summary
Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the… Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- Amg dose administration group and Bmg dose administration group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2023to 17 Feb 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females aged ≥ 19 and ≤ 45 years
- Subjects with a body mass index (BMI) ≥ 18.0 to ≤ 27.0 kg/m2
- Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests
- Agree to use dual contraceptive methods and not to donate eggs
- 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 17Show 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 pregnant or breast-feeding subject
- 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 Double-Blind, Placebo Controlled, Single Dosing, Dose-Escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, PK/PD of J2H-1702 After Oral Administration in Healthy Female Subjects
- Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects.
Read the detailed description
- Study Methodology: 6 Subjects will be randomized to the study group (J2H-1702 group) and 2 subjects will be to the placebo group. AE, VS, ECG, Lab tests will be evaluated to check the safety, tolerability and PK/PD.
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- Amg dose administration group, Amg dose administration group- Placebo, Bmg dose administration group, Bmg dose administration group- Placebo
- 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.
Amg dose administration groupDrug
Orally, Amg tablet single administration
Amg dose administration group- PlaceboDrug
Orally, Placebo Amg tablet single administration
Bmg dose administration groupDrug
Orally, Bmg tablet single administration
Bmg dose administration group- PlaceboDrug
Orally, Placebo Bmg tablet single administration
| Study group | Role | What they receive |
|---|---|---|
| Amg dose Group | Experimental | Amg dose administration group Receives: Drug: Amg dose administration group |
| Amg dose Group- Placebo | Placebo comparator | Amg dose administration group- Placebo Receives: Drug: Amg dose administration group- Placebo |
| Bmg dose Group | Experimental | Bmg dose administration group Receives: Drug: Bmg dose administration group |
| Bmg dose Group- Placebo | Placebo comparator | Bmg dose administration group- Placebo Receives: Drug: Bmg dose administration 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 start2 Jan 2023
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
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
- 16 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
- NCT06308874
- Sponsor's protocol ID
- JH-222-101
- 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 Double-Blind, Placebo Controlled, Single Dosing, Dose-Escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, PK/PD of J2H-1702 After Oral Administration in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT06308874
- Acronym / sponsor ID
- JH-222-101
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- J2H BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (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.
- Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects.
Detailed description
- Study Methodology: 6 Subjects will be randomized to the study group (J2H-1702 group) and 2 subjects will be to the placebo group. AE, VS, ECG, Lab tests will be evaluated to check the safety, tolerability and PK/PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amg dose Group | Experimental | Drug: Amg dose administration groupAmg dose administration group |
| Amg dose Group- Placebo | Placebo comparator | Drug: Amg dose administration group- PlaceboAmg dose administration group- Placebo |
| Bmg dose Group | Experimental | Drug: Bmg dose administration groupBmg dose administration group |
| Bmg dose Group- Placebo | Placebo comparator | Drug: Bmg dose administration group- PlaceboBmg dose administration group- Placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy females aged ≥ 19 and ≤ 45 years
- Subjects with a body mass index (BMI) ≥ 18.0 to ≤ 27.0 kg/m2
- Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests
- Agree to use dual contraceptive methods and not to donate eggs
- Voluntarily agree to participate in the study
Key exclusion criteria (17 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 |
|---|---|---|
| Amg dose administration groupOrally, Amg tablet single administration | Drug | Amg dose Group |
| Amg dose administration group- PlaceboOrally, Placebo Amg tablet single administration | Drug | Amg dose Group- Placebo |
| Bmg dose administration groupOrally, Bmg tablet single administration | Drug | Bmg dose Group |
| Bmg dose administration group- PlaceboOrally, Placebo Bmg tablet single administration | Drug | Bmg 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 Amg dose administration group and Bmg dose administration 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 17 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; AzTrials last refreshed its copy on 8 Nov 2026.