Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males

Summary

1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial

Conditions

• Non-alcoholic Steatohepatitis

Interventions

DRUG

Single administration Amg dose Group

Orally, Amg tablet single administration

DRUG

Single administration Bmg dose Group

Orally, Bmg tablet single administration

DRUG

Single administration Cmg dose Group

Orally, Cmg tablet single administration

DRUG

Single administration Dmg dose Group

Orally, Dmg tablet single administration

DRUG

Single administration Emg dose Group

Orally, Emg tablet single administration

DRUG

Single administration Amg dose Group-Placebo

Orally, Placebo Amg tablet, single administration

DRUG

Single administration Bmg dose Group-Placebo

Orally, Placebo Bmg tablet, single administration

DRUG

Single administration Cmg dose Group-Placebo

Orally, Placebo Cmg tablet, single administration

DRUG

Single administration Dmg dose Group-Placebo

Orally, Placebo Dmg tablet, single administration

DRUG

Single administration Emg dose Group-Placebo

Orally, Placebo Emg tablet, single administration

DRUG

Multiple administration Amg dose group

Orally, Amg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Bmg dose group

Orally, Bmg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Cmg dose group

Orally, Cmg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Dmg dose group

Orally, Dmg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Emg dose group

Orally, Emg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Amg dose group - Placebo

Orally, Placebo Amg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Bmg dose group - Placebo

Orally, Placebo Bmg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Cmg dose group - Placebo

Orally, Placebo Cmg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Dmg dose group - Placebo

Orally, Placebo Dmg 1 tablet, once a day for 3 days, multiple administration

DRUG

Multiple administration Emg dose group - Placebo

Orally, Placebo Emg 1 tablet, once a day for 3 days, multiple administration

Sponsors & Collaborators

• J2H Biotech

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-12

Primary Completion

2021-06-25

Completion

2021-07-13

Countries

• South Korea

Study Locations