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

J2H Biotech

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: Single administration Dmg dose Group; Drug: Single administration Bmg dose Group-Placebo; Drug: Single administration Cmg dose Group-Placebo; Drug: Single administration Bmg dose Group; Drug: Single administration Emg dose Group; Drug: Single administration Amg dose Group; Drug: Multiple administration Cmg dose group; Drug: Single administration Amg dose Group-Placebo; Drug: Multiple administration Emg dose group - Placebo; Drug: Multiple administration Emg dose group; Drug: Single administration Emg dose Group-Placebo; Drug: Multiple administration Dmg dose group - Placebo; Drug: Multiple administration Dmg dose group; Drug: Multiple administration Bmg dose group - Placebo; Drug: Single administration Cmg dose Group; Drug: Multiple administration Amg dose group - Placebo; Drug: Multiple administration Cmg dose group - Placebo; Drug: Multiple administration Bmg dose group; Drug: Multiple administration Amg dose group; Drug: Single administration Dmg dose Group-Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06308861

JH-201-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 20 patient groups, including a placebo group

Single administration Amg dose Group

Experimental group

Treatment:

Drug: Single administration Amg dose Group

Single administration Bmg dose Group

Experimental group

Treatment:

Drug: Single administration Bmg dose Group

Single administration Cmg dose Group

Experimental group

Treatment:

Drug: Single administration Cmg dose Group

Single administration Dmg dose Group

Experimental group

Treatment:

Drug: Single administration Dmg dose Group

Single administration Emg dose Group

Experimental group

Treatment:

Drug: Single administration Emg dose Group

Single administration Amg dose Group-Placebo

Placebo Comparator group

Treatment:

Drug: Single administration Amg dose Group-Placebo

Single administration Bmg dose Group-Placebo

Placebo Comparator group

Treatment:

Drug: Single administration Bmg dose Group-Placebo

Single administration Cmg dose Group-Placebo

Placebo Comparator group

Treatment:

Drug: Single administration Cmg dose Group-Placebo

Single administration Dmg dose Group-Placebo

Placebo Comparator group

Treatment:

Drug: Single administration Dmg dose Group-Placebo

Single administration Emg dose Group-Placebo

Placebo Comparator group

Treatment:

Drug: Single administration Emg dose Group-Placebo

Multiple administration Amg dose group

Experimental group

Treatment:

Drug: Multiple administration Amg dose group

Multiple administration Bmg dose group

Experimental group

Treatment:

Drug: Multiple administration Bmg dose group

Multiple administration Cmg dose group

Experimental group

Treatment:

Drug: Multiple administration Cmg dose group

Multiple administration Dmg dose group

Experimental group

Treatment:

Drug: Multiple administration Dmg dose group

Multiple administration Emg dose group

Experimental group

Treatment:

Drug: Multiple administration Emg dose group

Multiple administration Amg dose group - Placebo

Placebo Comparator group

Treatment:

Drug: Multiple administration Amg dose group - Placebo

Multiple administration Bmg dose group - Placebo

Placebo Comparator group

Treatment:

Drug: Multiple administration Bmg dose group - Placebo

Multiple administration Cmg dose group - Placebo

Placebo Comparator group

Treatment:

Drug: Multiple administration Cmg dose group - Placebo

Multiple administration Dmg dose group - Placebo

Placebo Comparator group

Treatment:

Drug: Multiple administration Dmg dose group - Placebo

Multiple administration Emg dose group - Placebo

Placebo Comparator group

Treatment:

Drug: Multiple administration Emg dose group - Placebo