Skip to main content
OpenTrials
Completed

NCT Number: NCT06308874

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

- 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

J2H Biotech

Suwon, Gyeonggi-do, 16684, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Amg dose administration group

Drug

Orally, Amg tablet single administration

Amg dose administration group- Placebo

Drug

Orally, Placebo Amg tablet single administration

Bmg dose administration group

Drug

Orally, Bmg tablet single administration

Bmg dose administration group- Placebo

Drug

Orally, Placebo Bmg tablet single administration

Primary outcomes

  1. Cmax

    Time frame: 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

  2. Emax

    Time frame: -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

Sponsors and collaborators

Lead sponsor

J2H Biotech

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.