drugset / Trial / NCT03896594

A Multiple Dose of HL237 in Healthy Male Subject

NCT03896594

Phase 1 Unknown 36 enrolled Hanlim Pharm. Co., Ltd.
RandomizedSequentialQuadruple-blindOther

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 repeated administration clinical trial performed for the development of HL237 and is intended to evaluate the safety, tolerability and pharmacokinetics of each dose group.

Timeline

Start
2018-12-24
Primary completion
2019-06-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject HL237 Unknown 100 mg Oral
Subject HL237 Unknown 200 mg Oral
Subject HL237 Unknown 400 mg Oral

Indications