Rheumatoid Arthritis
Conditions
Brief summary
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
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.
Interventions
DRUGHL237
Experimental
DRUGPlacebo Oral Tablet
placebo with same properties except for active ingredient
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | 14days after administration | maximum serum concentration after the drug has been administrated |
| Area Under the Curve [AUC] | 14days after administration | AUC after the drug has been administrated |
| Half life [t1/2] | 14days after administration | Half life after the drug has been administrated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | 14days after administration | Adverse Adverse Events, Serious Adverse Events |
Countries
South Korea
Contacts
Primary ContactSeunghun Han
Outcome results
None listed