drugset / Trial / NCT03278470

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

NCT03278470

Phase 1 Completed 57 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 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.

Timeline

Start
2017-06-26
Primary completion
2018-03-19
Completion
2018-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject HL237 Unknown 50 mg Oral
Subject HL237 Unknown 100 mg Oral
Subject HL237 Unknown 200 mg Oral
Subject HL237 Unknown 400 mg Oral
Subject HL237 Unknown 800 mg Oral
Subject HL237 Unknown 1200 mg Oral
Subject HL237 Unknown 1600 mg Oral

Indications