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NCT Number: NCT03278470

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The catholic university of korea seoul ST. mary's hospital

Soeul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

HL237

Drug

Experimental

Placebo oral tablet

Drug

placebo with same properties except for active ingredient

Primary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Time frame: 3days after administration

    maximum serum concentration after the drug has been administrated

  2. Area Under the Curve [AUC]

    Time frame: 3days after administration

  3. half life [t1/2]

    Time frame: 3days after administration

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 14days after administration

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2017
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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