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

NCT06308874 | Completed Phase 1

• 1 other identifier: JH-222-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (4)

Amg dose Group

EXPERIMENTAL

Amg dose administration group

Drug: Amg dose administration group

Amg dose Group- Placebo

PLACEBO COMPARATOR

Amg dose administration group- Placebo

Drug: Amg dose administration group- Placebo

Bmg dose Group

EXPERIMENTAL

Bmg dose administration group

Drug: Bmg dose administration group

Bmg dose Group- Placebo

PLACEBO COMPARATOR

Bmg dose administration group- Placebo

Drug: Bmg dose administration group- Placebo

Interventions

Amg dose administration group DRUG

Orally, Amg tablet single administration

Amg dose Group

Amg dose administration group- Placebo DRUG

Orally, Placebo Amg tablet single administration

Amg dose Group- Placebo

Bmg dose administration group DRUG

Orally, Bmg tablet single administration

Bmg dose Group

Bmg dose administration group- Placebo DRUG

Orally, Placebo Bmg tablet single administration

Bmg dose Group- Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females aged ≥ 19 and ≤ 45 years
• Subjects with a body mass index (BMI) ≥ 18.0 to ≤ 27.0 kg/m2
• Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests
• Agree to use dual contraceptive methods and not to donate eggs
• Voluntarily agree to participate in the study

You may not qualify if:

• A subject who had or has the disease corresponding to clinically significant liver, etc.
• A subject with a history of gastrointestinal diseases or surgery
• A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
• A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
• One who has drug abuse and one who is positive response in urine drug screening tests
• A subject with abnormal vital signs at the screening visit
• A subject who has participated in another clinical trial or bioequivalence test
• A subject who donated whole blood or the ingredient, or received blood transfusion
• A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
• A subject who consumes grapefruit/caffeine-containing food
• A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
• High caffeine intaker, high alcohol intaker or excessive smoker
• A subject who cannot eat meals provided by the Clinical Trial institution.
• A subject who participated in this trial and were administered the investigational product.
• A subject who is positive for serum test

Sponsors & Collaborators

• J2H Biotech: lead

Study Sites (1)

J2H Biotech

Suwon, Gyeonggi-do, 16684, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 13, 2024
• Study Start: January 2, 2023
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: December 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)