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
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2021
CompletedFirst Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedDecember 17, 2025
February 1, 2025
11 months
March 5, 2024
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax
Pharmacokinetics
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
-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)
Study Arms (20)
Single administration Amg dose Group
EXPERIMENTALSingle administration Bmg dose Group
EXPERIMENTALSingle administration Cmg dose Group
EXPERIMENTALSingle administration Dmg dose Group
EXPERIMENTALSingle administration Emg dose Group
EXPERIMENTALSingle administration Amg dose Group-Placebo
PLACEBO COMPARATORSingle administration Bmg dose Group-Placebo
PLACEBO COMPARATORSingle administration Cmg dose Group-Placebo
PLACEBO COMPARATORSingle administration Dmg dose Group-Placebo
PLACEBO COMPARATORSingle administration Emg dose Group-Placebo
PLACEBO COMPARATORMultiple administration Amg dose group
EXPERIMENTALMultiple administration Bmg dose group
EXPERIMENTALMultiple administration Cmg dose group
EXPERIMENTALMultiple administration Dmg dose group
EXPERIMENTALMultiple administration Emg dose group
EXPERIMENTALMultiple administration Amg dose group - Placebo
PLACEBO COMPARATORMultiple administration Bmg dose group - Placebo
PLACEBO COMPARATORMultiple administration Cmg dose group - Placebo
PLACEBO COMPARATORMultiple administration Dmg dose group - Placebo
PLACEBO COMPARATORMultiple administration Emg dose group - Placebo
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- J2H Biotechlead
Study Sites (1)
J2H Biotech
Suwon, Gyeonggi-do, 16684, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 13, 2024
Study Start
August 12, 2020
Primary Completion
June 25, 2021
Study Completion
July 13, 2021
Last Updated
December 17, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share