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A Multiple Dose of HL237 in Healthy Male Subject

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896594
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: HL237 Drug: Placebo Oral Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: HL237 200mg
HL237 100mg 1 tablet twice a day
Drug: HL237
Experimental

Drug: Placebo Oral Tablet
placebo with same properties except for active ingredient

Experimental: HL237 400mg
HL237 100mg 2 tablets twice a day
Drug: HL237
Experimental

Drug: Placebo Oral Tablet
placebo with same properties except for active ingredient

Experimental: HL237 800mg
HL237 400mg 1 tablet twice a day
Drug: HL237
Experimental

Drug: Placebo Oral Tablet
placebo with same properties except for active ingredient




Primary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] [ Time Frame: 14days after administration ]
    maximum serum concentration after the drug has been administrated

  2. Area Under the Curve [AUC] [ Time Frame: 14days after administration ]
    AUC after the drug has been administrated

  3. Half life [t1/2] [ Time Frame: 14days after administration ]
    Half life after the drug has been administrated


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 14days after administration ]
    Adverse Adverse Events, Serious Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896594


Contacts
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Contact: Seunghun Han 82-2-2258-7326 waystolove@catholic.ac.kr

Locations
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Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital Recruiting
Seoul, Seocho-gu, Korea, Republic of, 06591
Contact: Seunghun Han         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.

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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03896594    
Other Study ID Numbers: HL237-102
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases