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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:

A Double-Blind, Placebo Controlled, Single Dosing, Dose-Escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Characteristics of J2H-1702 After Oral Administration in Healthy Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308874
• Other study ID #: JH-222-101
• Status: Completed
• Phase: Phase 1
• Start date: January 2, 2023
• Est. completion date: February 17, 2023

Study information

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

Clinical Trial Summary

- Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects.

Description:

- Study Methodology: 6 Subjects will be randomized to the study group (J2H-1702 group) and 2 subjects will be to the placebo group. AE, VS, ECG, Lab tests will be evaluated to check the safety, tolerability and PK/PD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy females aged = 19 and = 45 years

2. Subjects with a body mass index (BMI) = 18.0 to = 27.0 kg/m2

3. Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests

4. Agree to use dual contraceptive methods and not to donate eggs

5. 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 pregnant or breast-feeding subject

17. 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:
• Amg dose administration group
Orally, Amg tablet single administration
• Amg dose administration group- Placebo
Orally, Placebo Amg tablet single administration
• Bmg dose administration group
Orally, Bmg tablet single administration
• Bmg dose administration group- Placebo
Orally, Placebo Bmg tablet single 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)