Rheumatoid Arthritis Clinical Trial
Official title:
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
Verified date | August 2018 |
Source | Hanlim Pharm. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | March 19, 2018 |
Est. primary completion date | March 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | The catholic university of korea seoul ST. mary's hospital | Soeul |
Lead Sponsor | Collaborator |
---|---|
Hanlim Pharm. Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Plasma Concentration [Cmax] | maximum serum concentration after the drug has been administrated | 3days after administration | |
Primary | Area Under the Curve [AUC] | 3days after administration | ||
Primary | half life [t1/2] | 3days after administration | ||
Secondary | Number of participants with treatment-related adverse events | 14days after administration |
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