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

Non-alcoholic Steatohepatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308861
• Other study ID #: JH-201-101
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: March 2024
• Source: J2H Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 13, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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 11ß-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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• Single administration Amg dose Group
Orally, Amg tablet single administration
• Single administration Bmg dose Group
Orally, Bmg tablet single administration
• Single administration Cmg dose Group
Orally, Cmg tablet single administration
• Single administration Dmg dose Group
Orally, Dmg tablet single administration
• Single administration Emg dose Group
Orally, Emg tablet single administration
• Single administration Amg dose Group-Placebo
Orally, Placebo Amg tablet, single administration
• Single administration Bmg dose Group-Placebo
Orally, Placebo Bmg tablet, single administration
• Single administration Cmg dose Group-Placebo
Orally, Placebo Cmg tablet, single administration
• Single administration Dmg dose Group-Placebo
Orally, Placebo Dmg tablet, single administration
• Single administration Emg dose Group-Placebo
Orally, Placebo Emg tablet, single administration
• Multiple administration Amg dose group
Orally, Amg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Bmg dose group
Orally, Bmg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Cmg dose group
Orally, Cmg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Dmg dose group
Orally, Dmg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Emg dose group
Orally, Emg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Amg dose group - Placebo
Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Bmg dose group - Placebo
Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Cmg dose group - Placebo
Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Dmg dose group - Placebo
Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration
• Multiple administration Emg dose group - Placebo
Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

Locations

Country	Name	City	State
Korea, Republic of	J2H Biotech	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
J2H Biotech

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)