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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
57
Experimental
placebo with same properties except for active ingredient
The catholic university of korea seoul ST. mary's hospital
Soeul, South Korea
Maximum Plasma Concentration [Cmax]
maximum serum concentration after the drug has been administrated
Time frame: 3days after administration
Area Under the Curve [AUC]
Time frame: 3days after administration
half life [t1/2]
Time frame: 3days after administration
Number of participants with treatment-related adverse events
Time frame: 14days after administration
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