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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single administration Amg dose Group | Experimental |
| |
| Single administration Bmg dose Group | Experimental |
| |
| Single administration Cmg dose Group | Experimental |
| |
| Single administration Dmg dose Group | Experimental |
| |
| Single administration Emg dose Group | Experimental |
| |
| Single administration Amg dose Group-Placebo | Placebo Comparator |
| |
| Single administration Bmg dose Group-Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single administration Amg dose Group | Drug | Orally, Amg tablet single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| J2H Biotech | Suwon | Gyeonggi-do | 16684 | South Korea |
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|
| Single administration Cmg dose Group-Placebo | Placebo Comparator |
|
| Single administration Dmg dose Group-Placebo | Placebo Comparator |
|
| Single administration Emg dose Group-Placebo | Placebo Comparator |
|
| Multiple administration Amg dose group | Experimental |
|
| Multiple administration Bmg dose group | Experimental |
|
| Multiple administration Cmg dose group | Experimental |
|
| Multiple administration Dmg dose group | Experimental |
|
| Multiple administration Emg dose group | Experimental |
|
| Multiple administration Amg dose group - Placebo | Placebo Comparator |
|
| Multiple administration Bmg dose group - Placebo | Placebo Comparator |
|
| Multiple administration Cmg dose group - Placebo | Placebo Comparator |
|
| Multiple administration Dmg dose group - Placebo | Placebo Comparator |
|
| Multiple administration Emg dose group - Placebo | Placebo Comparator |
|
| Single administration Bmg dose Group | Drug | Orally, Bmg tablet single administration |
|
| Single administration Cmg dose Group | Drug | Orally, Cmg tablet single administration |
|
| Single administration Dmg dose Group | Drug | Orally, Dmg tablet single administration |
|
| Single administration Emg dose Group | Drug | Orally, Emg tablet single administration |
|
| Single administration Amg dose Group-Placebo | Drug | Orally, Placebo Amg tablet, single administration |
|
| Single administration Bmg dose Group-Placebo | Drug | Orally, Placebo Bmg tablet, single administration |
|
| Single administration Cmg dose Group-Placebo | Drug | Orally, Placebo Cmg tablet, single administration |
|
| Single administration Dmg dose Group-Placebo | Drug | Orally, Placebo Dmg tablet, single administration |
|
| Single administration Emg dose Group-Placebo | Drug | Orally, Placebo Emg tablet, single administration |
|
| Multiple administration Amg dose group | Drug | Orally, Amg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Bmg dose group | Drug | Orally, Bmg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Cmg dose group | Drug | Orally, Cmg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Dmg dose group | Drug | Orally, Dmg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Emg dose group | Drug | Orally, Emg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Amg dose group - Placebo | Drug | Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Bmg dose group - Placebo | Drug | Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Cmg dose group - Placebo | Drug | Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Dmg dose group - Placebo | Drug | Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration |
|
| Multiple administration Emg dose group - Placebo | Drug | Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration |
|
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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