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Rheumatoid Arthritis

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

Sponsored by Hanlim Pharm. Co., Ltd.

About this trial

Last updated 7 years ago

Study ID

HL-237-101

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
20 to 45 Years
Male
Male

Trial Timing

Ended 7 years ago

What is this trial 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.

What are the participation requirements?

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

No

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.)