Phase 1 Study to 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. 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

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Steatohepatitis
• Intervention / Treatment: Drug: Single administration Amg dose Group; Drug: Single administration Bmg dose Group; Drug: Single administration Cmg dose Group; Drug: Single administration Dmg dose Group; Drug: Single administration Emg dose Group; Drug: Single administration Amg dose Group-Placebo; Drug: Single administration Bmg dose Group-Placebo; Drug: Single administration Cmg dose Group-Placebo; Drug: Single administration Dmg dose Group-Placebo; Drug: Single administration Emg dose Group-Placebo; Drug: Multiple administration Amg dose group; Drug: Multiple administration Bmg dose group; Drug: Multiple administration Cmg dose group; Drug: Multiple administration Dmg dose group; Drug: Multiple administration Emg dose group; Drug: Multiple administration Amg dose group - Placebo; Drug: Multiple administration Bmg dose group - Placebo; Drug: Multiple administration Cmg dose group - Placebo; Drug: Multiple administration Dmg dose group - Placebo; Drug: Multiple administration Emg dose group - Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16684
      • J2H Biotech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

20

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single administration Amg dose Group	Drug: Single administration Amg dose Group; Orally, Amg tablet single administration
Experimental: Single administration Bmg dose Group	Drug: Single administration Bmg dose Group; Orally, Bmg tablet single administration
Experimental: Single administration Cmg dose Group	Drug: Single administration Cmg dose Group; Orally, Cmg tablet single administration
Experimental: Single administration Dmg dose Group	Drug: Single administration Dmg dose Group; Orally, Dmg tablet single administration
Experimental: Single administration Emg dose Group	Drug: Single administration Emg dose Group; Orally, Emg tablet single administration
Placebo Comparator: Single administration Amg dose Group-Placebo	Drug: Single administration Amg dose Group-Placebo; Orally, Placebo Amg tablet, single administration
Placebo Comparator: Single administration Bmg dose Group-Placebo	Drug: Single administration Bmg dose Group-Placebo; Orally, Placebo Bmg tablet, single administration
Placebo Comparator: Single administration Cmg dose Group-Placebo	Drug: Single administration Cmg dose Group-Placebo; Orally, Placebo Cmg tablet, single administration
Placebo Comparator: Single administration Dmg dose Group-Placebo	Drug: Single administration Dmg dose Group-Placebo; Orally, Placebo Dmg tablet, single administration
Placebo Comparator: Single administration Emg dose Group-Placebo	Drug: Single administration Emg dose Group-Placebo; Orally, Placebo Emg tablet, single administration
Experimental: Multiple administration Amg dose group	Drug: Multiple administration Amg dose group; Orally, Amg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Bmg dose group	Drug: Multiple administration Bmg dose group; Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Cmg dose group	Drug: Multiple administration Cmg dose group; Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Dmg dose group	Drug: Multiple administration Dmg dose group; Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
Experimental: Multiple administration Emg dose group	Drug: Multiple administration Emg dose group; Orally, Emg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Amg dose group - Placebo	Drug: Multiple administration Amg dose group - Placebo; Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Bmg dose group - Placebo	Drug: Multiple administration Bmg dose group - Placebo; Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Cmg dose group - Placebo	Drug: Multiple administration Cmg dose group - Placebo; Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Dmg dose group - Placebo	Drug: Multiple administration Dmg dose group - Placebo; Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
Placebo Comparator: Multiple administration Emg dose group - Placebo	Drug: Multiple administration Emg dose group - Placebo; Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: J2H Biotech

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): June 25, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: JH-201-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No