Phase 1 to Investigate Safety, Tolerability, PK/PK of J2H-1702 in Healthy Males

Phase 1

Completed

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: Multiple administration Dmg dose group; Drug: Multiple administration Amg dose group - Placebo; Drug: Single administration Amg dose Group; Drug: Multiple administration Cmg dose group; Drug: Single administration Cmg dose Group; Drug: Single administration Amg dose Group-Placebo; Drug: Single administration Emg dose Group-Placebo; Drug: Multiple administration Amg dose group; Drug: Multiple administration Emg dose group; Drug: Multiple administration Dmg dose group - Placebo; Drug: Multiple administration Bmg dose group; Drug: Single administration Bmg dose Group; Drug: Single administration Dmg dose Group; Drug: Single administration Emg dose Group; Drug: Single administration Bmg dose Group-Placebo; Drug: Single administration Cmg dose Group-Placebo; Drug: Single administration Dmg dose Group-Placebo; Drug: Multiple administration Emg dose group - Placebo; Drug: Multiple administration Cmg dose group - Placebo; Drug: Multiple administration Bmg dose group - Placebo

• Registration Number: NCT06308861
• Lead Sponsor: J2H Biotech

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

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 Timeline

• Study Start: 2020-08-12
• Primary Completion: 2021-06-25
• Study Completion: 2021-07-13
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple administration Dmg dose group	Multiple administration Dmg dose group	-
Multiple administration Amg dose group - Placebo	Multiple administration Amg dose group - Placebo	-
Single administration Amg dose Group	Single administration Amg dose Group	-
Multiple administration Cmg dose group	Multiple administration Cmg dose group	-
Single administration Cmg dose Group	Single administration Cmg dose Group	-
Single administration Amg dose Group-Placebo	Single administration Amg dose Group-Placebo	-
Single administration Emg dose Group-Placebo	Single administration Emg dose Group-Placebo	-
Multiple administration Amg dose group	Multiple administration Amg dose group	-
Multiple administration Emg dose group	Multiple administration Emg dose group	-
Multiple administration Dmg dose group - Placebo	Multiple administration Dmg dose group - Placebo	-
Multiple administration Bmg dose group	Multiple administration Bmg dose group	-
Single administration Bmg dose Group	Single administration Bmg dose Group	-
Single administration Dmg dose Group	Single administration Dmg dose Group	-
Single administration Emg dose Group	Single administration Emg dose Group	-
Single administration Bmg dose Group-Placebo	Single administration Bmg dose Group-Placebo	-
Single administration Cmg dose Group-Placebo	Single administration Cmg dose Group-Placebo	-
Single administration Dmg dose Group-Placebo	Single administration Dmg dose Group-Placebo	-
Multiple administration Emg dose group - Placebo	Multiple administration Emg dose group - Placebo	-
Multiple administration Cmg dose group - Placebo	Multiple administration Cmg dose group - Placebo	-
Multiple administration Bmg dose group - Placebo	Multiple administration Bmg dose group - Placebo	-

Primary Outcome Measures

Name	Time	Method
Cmax	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
Emax	-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

Trial Locations

Locations (1)

J2H Biotech; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of