Phase 2a study for NASH
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008007
- Lead Sponsor
- J2H Biotech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 16
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
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 11ß-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 pregnanct or breast-feeding subject
17) A subject who the investigator deems inappropriate for this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vital sign, Physical exam, 12-lead ECG, Clinical laboratory tests, Drug screen and serology etc.
- Secondary Outcome Measures
Name Time Method Cmax, AUClast, AUCinf, Tmax, t1/2, fe, CLR, CL/F, Vz/F;Serum cortisol- ?Emax and ?AUEClast/ 24-hour urinary free cortisol- ?Eufc