A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable 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 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.

Official Title
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A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single 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 50mg<br>take oral tablet once | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 100mg<br>take oral tablet once | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 200mg<br>take oral tablet once | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 400mg<br>take oral tablet once | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 800mg<br>take oral tablet once | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 1200mg<br>take oral tablet once | Drug: HL237<br>* Experimental<br>Drug: Placebo Oral Tablet<br>* placebo with same properties except for active ingredient<br>|
| Experimental: HL237 1600mg<br>take oral tablet once | 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 | 3days after administration | 
| Area Under the Curve [AUC] |  | 3days after administration | 
| half life [t1/2] |  | 3days after administration | 

Secondary Outcome Measures

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