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

Phase 1

Completed

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: Bmg dose administration group; Drug: Amg dose administration group- Placebo; Drug: Amg dose administration group; Drug: Bmg dose administration group- Placebo

• Registration Number: NCT06308874
• Lead Sponsor: J2H Biotech

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-02
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• 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: Female
• Target Recruitment: 16

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 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 pregnant or breast-feeding subject
17. A subject who the investigator deems inappropriate for this clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bmg dose Group	Bmg dose administration group	Bmg dose administration group
Amg dose Group- Placebo	Amg dose administration group- Placebo	Amg dose administration group- Placebo
Amg dose Group	Amg dose administration group	Amg dose administration group
Bmg dose Group- Placebo	Bmg dose administration group- Placebo	Bmg dose administration 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