Skip to main content
OpenTrials
Completed

NCT Number: NCT06308861

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

J2H Biotech

Suwon, Gyeonggi-do, 16684, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A healthy male adult within the range of 19 to 45 years old
  • BMI=18.0~27.0kg/m2 (Body mass index, BMI)
  • A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
  • A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
  • A subject who has voluntarily agree to participate in the study

Exclusion criteria

  • A subject who had or has the disease corresponding to clinically significant liver, etc.
  • A subject with a history of gastrointestinal diseases or surgery
  • A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
  • A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
  • One who has drug abuse and one who is positive response in urine drug screening tests
  • A subject with abnormal vital signs at the screening visit
  • A subject who has participated in another clinical trial or bioequivalence test
  • A subject who donated whole blood or the ingredient, or received blood transfusion
  • A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
  • A subject who consumes grapefruit/caffeine-containing food
  • A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
  • High caffeine intaker, high alcohol intaker or excessive smoker
  • A subject who cannot eat meals provided by the Clinical Trial institution.
  • A subject who participated in this trial and were administered the investigational product.
  • A subject who is positive for serum test
  • A subject who the investigator deems inappropriate for this clinical trial.

Treatment and study plan

Single administration Amg dose Group

Drug

Orally, Amg tablet single administration

Single administration Bmg dose Group

Drug

Orally, Bmg tablet single administration

Single administration Cmg dose Group

Drug

Orally, Cmg tablet single administration

Single administration Dmg dose Group

Drug

Orally, Dmg tablet single administration

Single administration Emg dose Group

Drug

Orally, Emg tablet single administration

Single administration Amg dose Group-Placebo

Drug

Orally, Placebo Amg tablet, single administration

Single administration Bmg dose Group-Placebo

Drug

Orally, Placebo Bmg tablet, single administration

Single administration Cmg dose Group-Placebo

Drug

Orally, Placebo Cmg tablet, single administration

Single administration Dmg dose Group-Placebo

Drug

Orally, Placebo Dmg tablet, single administration

Single administration Emg dose Group-Placebo

Drug

Orally, Placebo Emg tablet, single administration

Multiple administration Amg dose group

Drug

Orally, Amg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Bmg dose group

Drug

Orally, Bmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Cmg dose group

Drug

Orally, Cmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Dmg dose group

Drug

Orally, Dmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Emg dose group

Drug

Orally, Emg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Amg dose group - Placebo

Drug

Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Bmg dose group - Placebo

Drug

Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Cmg dose group - Placebo

Drug

Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Dmg dose group - Placebo

Drug

Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration

Multiple administration Emg dose group - Placebo

Drug

Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

Primary outcomes

  1. Cmax

    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

  2. Emax

    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

Sponsors and collaborators

Lead sponsor

J2H Biotech

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2024
Registry last updated
Dec 17, 2025

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.

Published trials that share one or more normalized conditions with this study.