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

NCT ID: NCT06308861

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-07-13

Brief Summary

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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

Detailed Description

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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

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Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multiple administration Dmg dose group

Group Type EXPERIMENTAL

Multiple administration Dmg dose group

Intervention Type DRUG

Orally, Dmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Emg dose group

Group Type EXPERIMENTAL

Multiple administration Emg dose group

Intervention Type DRUG

Orally, Emg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Amg dose group - Placebo

Group Type PLACEBO_COMPARATOR

Multiple administration Amg dose group - Placebo

Intervention Type DRUG

Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Bmg dose group - Placebo

Group Type PLACEBO_COMPARATOR

Multiple administration Bmg dose group - Placebo

Intervention Type DRUG

Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Cmg dose group - Placebo

Group Type PLACEBO_COMPARATOR

Multiple administration Cmg dose group - Placebo

Intervention Type DRUG

Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Dmg dose group - Placebo

Group Type PLACEBO_COMPARATOR

Multiple administration Dmg dose group - Placebo

Intervention Type DRUG

Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Emg dose group - Placebo

Group Type PLACEBO_COMPARATOR

Multiple administration Emg dose group - Placebo

Intervention Type DRUG

Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

Single administration Amg dose Group

Group Type EXPERIMENTAL

Single administration Amg dose Group

Intervention Type DRUG

Orally, Amg tablet single administration

Single administration Bmg dose Group

Group Type EXPERIMENTAL

Single administration Bmg dose Group

Intervention Type DRUG

Orally, Bmg tablet single administration

Single administration Cmg dose Group

Group Type EXPERIMENTAL

Single administration Cmg dose Group

Intervention Type DRUG

Orally, Cmg tablet single administration

Single administration Dmg dose Group

Group Type EXPERIMENTAL

Single administration Dmg dose Group

Intervention Type DRUG

Orally, Dmg tablet single administration

Single administration Emg dose Group

Group Type EXPERIMENTAL

Single administration Emg dose Group

Intervention Type DRUG

Orally, Emg tablet single administration

Single administration Amg dose Group-Placebo

Group Type PLACEBO_COMPARATOR

Single administration Amg dose Group-Placebo

Intervention Type DRUG

Orally, Placebo Amg tablet, single administration

Single administration Bmg dose Group-Placebo

Group Type PLACEBO_COMPARATOR

Single administration Bmg dose Group-Placebo

Intervention Type DRUG

Orally, Placebo Bmg tablet, single administration

Single administration Cmg dose Group-Placebo

Group Type PLACEBO_COMPARATOR

Single administration Cmg dose Group-Placebo

Intervention Type DRUG

Orally, Placebo Cmg tablet, single administration

Single administration Dmg dose Group-Placebo

Group Type PLACEBO_COMPARATOR

Single administration Dmg dose Group-Placebo

Intervention Type DRUG

Orally, Placebo Dmg tablet, single administration

Single administration Emg dose Group-Placebo

Group Type PLACEBO_COMPARATOR

Single administration Emg dose Group-Placebo

Intervention Type DRUG

Orally, Placebo Emg tablet, single administration

Multiple administration Amg dose group

Group Type EXPERIMENTAL

Multiple administration Amg dose group

Intervention Type DRUG

Orally, Amg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Bmg dose group

Group Type EXPERIMENTAL

Multiple administration Bmg dose group

Intervention Type DRUG

Orally, Bmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Cmg dose group

Group Type EXPERIMENTAL

Multiple administration Cmg dose group

Intervention Type DRUG

Orally, Cmg 1 tablet, once a day for 3 days, multiple administration

Interventions

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Single administration Amg dose Group

Orally, Amg tablet single administration

Intervention Type DRUG

Single administration Bmg dose Group

Orally, Bmg tablet single administration

Intervention Type DRUG

Single administration Cmg dose Group

Orally, Cmg tablet single administration

Intervention Type DRUG

Single administration Dmg dose Group

Orally, Dmg tablet single administration

Intervention Type DRUG

Single administration Emg dose Group

Orally, Emg tablet single administration

Intervention Type DRUG

Single administration Amg dose Group-Placebo

Orally, Placebo Amg tablet, single administration

Intervention Type DRUG

Single administration Bmg dose Group-Placebo

Orally, Placebo Bmg tablet, single administration

Intervention Type DRUG

Single administration Cmg dose Group-Placebo

Orally, Placebo Cmg tablet, single administration

Intervention Type DRUG

Single administration Dmg dose Group-Placebo

Orally, Placebo Dmg tablet, single administration

Intervention Type DRUG

Single administration Emg dose Group-Placebo

Orally, Placebo Emg tablet, single administration

Intervention Type DRUG

Multiple administration Amg dose group

Orally, Amg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Bmg dose group

Orally, Bmg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Cmg dose group

Orally, Cmg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Dmg dose group

Orally, Dmg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Emg dose group

Orally, Emg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Amg dose group - Placebo

Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Bmg dose group - Placebo

Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Cmg dose group - Placebo

Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Dmg dose group - Placebo

Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Multiple administration Emg dose group - Placebo

Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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J2H Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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J2H Biotech

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JH-201-101

Identifier Type: -

Identifier Source: org_study_id