A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject

Hanlim Pharm

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo Oral Tablet; Drug: HL237

Study type: Interventional

Funder types: Industry

Identifiers

NCT03278470

HL-237-101

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 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.

Enrollment: 57 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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57 participants in 7 patient groups

HL237 50mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet

HL237 100mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet

HL237 200mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet

HL237 400mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet

HL237 800mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet

HL237 1200mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet

HL237 1600mg

Experimental group

Description:

take oral tablet once

Treatment:

Drug: HL237

Drug: Placebo Oral Tablet