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.
Doses are increased sequentially from low-capacity groups, and within six weeks after the last dose of the last subject in the ongoing dose phase, if available pharmacokinetic data are judged acceptable under review by investigators, sponsor and safety review committees, then proceed to the next dose stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
36
Experimental
placebo with same properties except for active ingredient
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu, South Korea
RECRUITINGMaximum Plasma Concentration [Cmax]
maximum serum concentration after the drug has been administrated
Time frame: 14days after administration
Area Under the Curve [AUC]
AUC after the drug has been administrated
Time frame: 14days after administration
Half life [t1/2]
Half life after the drug has been administrated
Time frame: 14days after administration
Number of participants with treatment-related adverse events
Adverse Adverse Events, Serious Adverse Events
Time frame: 14days after administration
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