A Multiple Dose of HL237 in Healthy Male Subject

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: HL237
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy adult male aged 20 years or older and 45 years old at the time of the screening test Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight Proper contraception during the clinical trial period After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement Exclusion Criteria: Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery) a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HL237 200mg<br>HL237 100mg 1 tablet twice a day | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 400mg<br>HL237 100mg 2 tablets twice a day | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 800mg<br>HL237 400mg 1 tablet twice a day | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration [Cmax] | maximum serum concentration after the drug has been administrated | 14days after administration | 
| Area Under the Curve [AUC] | AUC after the drug has been administrated | 14days after administration | 
| Half life [t1/2] | Half life after the drug has been administrated | 14days after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Adverse Adverse Events, Serious Adverse Events | 14days after administration |