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

J2H Biotech

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: Amg dose administration group; Drug: Amg dose administration group- Placebo; Drug: Bmg dose administration group- Placebo; Drug: Bmg dose administration group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06308874

JH-222-101

Details and patient eligibility

About

- 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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups, including a placebo group

Amg dose Group

Experimental group

Description:

Amg dose administration group

Treatment:

Drug: Amg dose administration group

Amg dose Group- Placebo

Placebo Comparator group

Description:

Amg dose administration group- Placebo

Treatment:

Drug: Amg dose administration group- Placebo

Bmg dose Group

Experimental group

Description:

Bmg dose administration group

Treatment:

Drug: Bmg dose administration group

Bmg dose Group- Placebo

Placebo Comparator group

Description:

Bmg dose administration group- Placebo

Treatment:

Drug: Bmg dose administration group- Placebo