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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Orally, Amg tablet single administration
Orally, Bmg tablet single administration
Orally, Cmg tablet single administration
J2H Biotech
Suwon, Gyeonggi-do, South Korea
Cmax
Pharmacokinetics
Time frame: 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
Time frame: -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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orally, Dmg tablet single administration
Orally, Emg tablet single administration
Orally, Placebo Amg tablet, single administration
Orally, Placebo Bmg tablet, single administration
Orally, Placebo Cmg tablet, single administration
Orally, Placebo Dmg tablet, single administration
Orally, Placebo Emg tablet, single administration
Orally, Amg 1 tablet, once a day for 3 days, multiple administration
Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
Orally, Emg 1 tablet, once a day for 3 days, multiple administration
Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration