NCT06308874

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: J2H Biotech · Industry
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Amg dose administration group	Orally, Amg tablet single administration
DRUG	Amg dose administration group- Placebo	Orally, Placebo Amg tablet single administration
DRUG	Bmg dose administration group	Orally, Bmg tablet single administration
DRUG	Bmg dose administration group- Placebo	Orally, Placebo Bmg tablet single administration

Timeline

• Start date: 2023-01-02
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2024-03-13
• Last updated: 2025-12-17

Locations

1 site across 1 country: South Korea