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- 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.
- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amg dose Group | Experimental | Amg dose administration group |
|
| Amg dose Group- Placebo | Placebo Comparator | Amg dose administration group- Placebo |
|
| Bmg dose Group | Experimental | Bmg dose administration group |
|
| Bmg dose Group- Placebo | Placebo Comparator | Bmg dose administration group- Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amg dose administration 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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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Amg dose administration group- Placebo |
| Drug |
Orally, Placebo Amg tablet single administration |
|
| Bmg dose administration group | Drug | Orally, Bmg tablet single administration |
|
| Bmg dose administration group- Placebo | Drug | Orally, Placebo Bmg tablet single administration |
|