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A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278470
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE June 26, 2017
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • Maximum Plasma Concentration [Cmax] [ Time Frame: 3days after administration ]
    maximum serum concentration after the drug has been administrated
  • Area Under the Curve [AUC] [ Time Frame: 3days after administration ]
  • half life [t1/2] [ Time Frame: 3days after administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
Number of participants with treatment-related adverse events [ Time Frame: 14days after administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
Official Title  ICMJE 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
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: HL237
    Experimental
  • Drug: Placebo Oral Tablet
    placebo with same properties except for active ingredient
Study Arms  ICMJE
  • Experimental: HL237 50mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
  • Experimental: HL237 100mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
  • Experimental: HL237 200mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
  • Experimental: HL237 400mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
  • Experimental: HL237 800mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
  • Experimental: HL237 1200mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
  • Experimental: HL237 1600mg
    take oral tablet once
    Interventions:
    • Drug: HL237
    • Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2018)
57
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
56
Actual Study Completion Date  ICMJE March 19, 2018
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278470
Other Study ID Numbers  ICMJE HL-237-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanlim Pharm. Co., Ltd.
Study Sponsor  ICMJE Hanlim Pharm. Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hanlim Pharm. Co., Ltd.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP