Non-alcoholic Steatohepatitis
Conditions
Brief 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 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.
Interventions
DRUGAmg dose administration group
Orally, Amg tablet single administration
DRUGAmg dose administration group- Placebo
Orally, Placebo Amg tablet single administration
DRUGBmg dose administration group
Orally, Bmg tablet single administration
DRUGBmg dose administration group- Placebo
Orally, Placebo Bmg tablet single administration
Sponsors
J2H Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy females aged ≥ 19 and ≤ 45 years 2. Subjects with a body mass index (BMI) ≥ 18.0 to ≤ 27.0 kg/m2 3. Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests 4. Agree to use dual contraceptive methods and not to donate eggs 5. 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 pregnant or breast-feeding subject 17. A subject who the investigator deems inappropriate for this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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 | -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 |
Countries
South Korea
Outcome results
None listed