A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
NCT ID: NCT03278470
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2017-06-26
2018-03-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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HL237 50mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
HL237 100mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
HL237 200mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
HL237 400mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
HL237 800mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
HL237 1200mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
HL237 1600mg
take oral tablet once
HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
Interventions
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HL237
Experimental
Placebo Oral Tablet
placebo with same properties except for active ingredient
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
20 Years
45 Years
MALE
Yes
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The catholic university of korea seoul ST. mary's hospital
Soeul, , South Korea
Countries
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Other Identifiers
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HL-237-101
Identifier Type: -
Identifier Source: org_study_id
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