None listed
Conditions
Interventions
Drug : 1) study group 1 (J2H-1702 Amg)
2) study group 2 (J2H-1702 Bmg)
3) study grouop 3 (J2H-1702 Cmg)
4) control group (Placebo of J2H-1702)
Each group of the study 1, 2, 3 and placebo has 20 sub
Sponsors
J2H Biotech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A subject aged =19 years to =75 years 2) Meeting all of the following criteria: ? Screening MRI-PDFF with =8% steatosis ? Screening MRE with liver stiffness =2.5 kPa ? ALT or AST =250 IU/L at screening 3) Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study 4) Voluntarily provide written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) A subject who has past or current history of liver diseases 2) A subject who has the following medical or surgical history - Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11ß-HSD1 inhibitor or same class 3) A subject who has the following concomitant diseases - liver disease, uncontrolled hypertension, uncontrolled DM, etc. 4) A subject who has taken the following medications - Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc. 5) A subject who has taken IP of another study 6) A subject who does not agree with appropriate methods of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: 1) Adverse events (AEs), 2) Vital signs, 3) Laboratory tests, 4) Electrocardiogram (ECG);MRI-PDFF, MRE | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body weight and BMI at the time of 12 weeks from baseline, etc. | — |
Countries
Korea, Republic of
Contacts
Public ContactDae Won Jun
Hanyang University
Outcome results
None listed