A Multiple Dose of HL237 in Healthy Male Subject

Hanlim Pharm

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo Oral Tablet; Drug: HL237

Study type: Interventional

Funder types: Industry

Identifiers

NCT03896594

HL237-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

HL237 200mg

Experimental group

Description:

HL237 100mg 1 tablet twice a day

Treatment:

Drug: Placebo Oral Tablet

Drug: HL237

HL237 400mg

Experimental group

Description:

HL237 100mg 2 tablets twice a day

Treatment:

Drug: Placebo Oral Tablet

Drug: HL237

HL237 800mg

Experimental group

Description:

HL237 400mg 1 tablet twice a day

Treatment:

Drug: Placebo Oral Tablet

Drug: HL237