Back to resultsA Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL237
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis
Eligibility 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.)
Sites / Locations
- The catholic university of korea seoul ST. mary's hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
HL237 50mg
HL237 100mg
HL237 200mg
HL237 400mg
HL237 800mg
HL237 1200mg
HL237 1600mg
Arm Description
take oral tablet once
take oral tablet once
take oral tablet once
take oral tablet once
take oral tablet once
take oral tablet once
take oral tablet once
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration [Cmax]
maximum serum concentration after the drug has been administrated
Area Under the Curve [AUC]
half life [t1/2]
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Full Information
NCT ID
NCT03278470
First Posted
September 7, 2017
Last Updated
August 16, 2018
Sponsor
Hanlim Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03278470
Brief Title
A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
March 19, 2018 (Actual)
Study Completion Date
March 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HL237 50mg
Arm Type
Experimental
Arm Description
take oral tablet once
Arm Title
HL237 100mg
Arm Type
Experimental
Arm Description
take oral tablet once
Arm Title
HL237 200mg
Arm Type
Experimental
Arm Description
take oral tablet once
Arm Title
HL237 400mg
Arm Type
Experimental
Arm Description
take oral tablet once
Arm Title
HL237 800mg
Arm Type
Experimental
Arm Description
take oral tablet once
Arm Title
HL237 1200mg
Arm Type
Experimental
Arm Description
take oral tablet once
Arm Title
HL237 1600mg
Arm Type
Experimental
Arm Description
take oral tablet once
Intervention Type
Drug
Intervention Name(s)
HL237
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebo with same properties except for active ingredient
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration [Cmax]
Description
maximum serum concentration after the drug has been administrated
Time Frame
3days after administration
Title
Area Under the Curve [AUC]
Time Frame
3days after administration
Title
half life [t1/2]
Time Frame
3days after administration
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
14days after administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.)
Facility Information:
Facility Name
The catholic university of korea seoul ST. mary's hospital
City
Soeul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
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