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A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject

Rheumatoid Arthritis Clinical Trial

Official title:
A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject

Clinical Trial Summary

HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug.

The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3 inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and activating Treg cells.

Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis.

This is the first clinical trial to be conducted for the development of HL237 and this clinical trial is for determining the maximum oral dose of HL237 and assessing safety, tolerability, and pharmacokinetic characteristics for each dose group.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03278470
Study type Interventional
Source Hanlim Pharm. Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 26, 2017
Completion date March 19, 2018
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