J2H Biotech
Suwon, Gyeonggi-do, 16684, South Korea
NCT Number: NCT06308861
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
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Notify Me19 year–45 year
Male
Interventional
Phase 1
Suwon, Gyeonggi-do, 16684, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orally, Amg tablet single administration
Orally, Bmg tablet single administration
Orally, Cmg tablet single administration
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
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)
Pharmacokinetics
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)
Pharmacodynamics
J2H Biotech
Industry
A Dose Block-randomized, Double-blind, Placebo Controlled, Single and Multiple-dosing, Dose-escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, PK/PD of J2H-1702 After Oral Administration in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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