NCT06308861

Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: J2H Biotech · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Single administration Amg dose Group	Orally, Amg tablet single administration
DRUG	Single administration Bmg dose Group	Orally, Bmg tablet single administration
DRUG	Single administration Cmg dose Group	Orally, Cmg tablet single administration
DRUG	Single administration Dmg dose Group	Orally, Dmg tablet single administration
DRUG	Single administration Emg dose Group	Orally, Emg tablet single administration
DRUG	Single administration Amg dose Group-Placebo	Orally, Placebo Amg tablet, single administration
DRUG	Single administration Bmg dose Group-Placebo	Orally, Placebo Bmg tablet, single administration
DRUG	Single administration Cmg dose Group-Placebo	Orally, Placebo Cmg tablet, single administration
DRUG	Single administration Dmg dose Group-Placebo	Orally, Placebo Dmg tablet, single administration
DRUG	Single administration Emg dose Group-Placebo	Orally, Placebo Emg tablet, single administration
DRUG	Multiple administration Amg dose group	Orally, Amg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Bmg dose group	Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Cmg dose group	Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Dmg dose group	Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Emg dose group	Orally, Emg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Amg dose group - Placebo	Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Bmg dose group - Placebo	Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Cmg dose group - Placebo	Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Dmg dose group - Placebo	Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
DRUG	Multiple administration Emg dose group - Placebo	Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

Timeline

• Start date: 2020-08-12
• Primary completion: 2021-06-25
• Completion: 2021-07-13
• First posted: 2024-03-13
• Last updated: 2025-12-17

Locations

1 site across 1 country: South Korea