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

NCT ID: NCT06308874

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2023-02-17

Brief Summary

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\- 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

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\- 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.

Conditions

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Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amg dose Group

Amg dose administration group

Group Type EXPERIMENTAL

Amg dose administration group

Intervention Type DRUG

Orally, Amg tablet single administration

Amg dose Group- Placebo

Amg dose administration group- Placebo

Group Type PLACEBO_COMPARATOR

Amg dose administration group- Placebo

Intervention Type DRUG

Orally, Placebo Amg tablet single administration

Bmg dose Group

Bmg dose administration group

Group Type EXPERIMENTAL

Bmg dose administration group

Intervention Type DRUG

Orally, Bmg tablet single administration

Bmg dose Group- Placebo

Bmg dose administration group- Placebo

Group Type PLACEBO_COMPARATOR

Bmg dose administration group- Placebo

Intervention Type DRUG

Orally, Placebo Bmg tablet single administration

Interventions

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Amg dose administration group

Orally, Amg tablet single administration

Intervention Type DRUG

Amg dose administration group- Placebo

Orally, Placebo Amg tablet single administration

Intervention Type DRUG

Bmg dose administration group

Orally, Bmg tablet single administration

Intervention Type DRUG

Bmg dose administration group- Placebo

Orally, Placebo Bmg tablet single administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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J2H Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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J2H Biotech

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JH-222-101

Identifier Type: -

Identifier Source: org_study_id