Non-alcoholic Steatohepatitis
Conditions
Brief summary
1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men. 2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial
Detailed description
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.
Interventions
DRUGSingle administration Amg dose Group
Orally, Amg tablet single administration
DRUGSingle administration Bmg dose Group
Orally, Bmg tablet single administration
DRUGSingle administration Cmg dose Group
Orally, Cmg tablet single administration
DRUGSingle administration Dmg dose Group
Orally, Dmg tablet single administration
DRUGSingle administration Emg dose Group
Orally, Emg tablet single administration
DRUGSingle administration Amg dose Group-Placebo
Orally, Placebo Amg tablet, single administration
DRUGSingle administration Bmg dose Group-Placebo
Orally, Placebo Bmg tablet, single administration
DRUGSingle administration Cmg dose Group-Placebo
Orally, Placebo Cmg tablet, single administration
DRUGSingle administration Dmg dose Group-Placebo
Orally, Placebo Dmg tablet, single administration
DRUGSingle administration Emg dose Group-Placebo
Orally, Placebo Emg tablet, single administration
DRUGMultiple administration Amg dose group
Orally, Amg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Bmg dose group
Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Cmg dose group
Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Dmg dose group
Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Emg dose group
Orally, Emg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Amg dose group - Placebo
Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Bmg dose group - Placebo
Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Cmg dose group - Placebo
Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Dmg dose group - Placebo
Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
DRUGMultiple administration Emg dose group - Placebo
Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration
Sponsors
J2H Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. A healthy male adult within the range of 19 to 45 years old 2. BMI=18.0\ 27.0kg/m2 (Body mass index, BMI) 3. A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests 4. A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms 5. A subject who has 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 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