Back to resultsA Multiple Dose of HL237 in Healthy Male Subject
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
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 HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
HL237 200mg
HL237 400mg
HL237 800mg
Arm Description
HL237 100mg 1 tablet twice a day
HL237 100mg 2 tablets twice a day
HL237 400mg 1 tablet twice a day
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration [Cmax]
maximum serum concentration after the drug has been administrated
Area Under the Curve [AUC]
AUC after the drug has been administrated
Half life [t1/2]
Half life after the drug has been administrated
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Adverse Adverse Events, Serious Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03896594
Brief Title
A Multiple Dose of HL237 in Healthy Male Subject
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
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 repeated administration clinical trial performed for the development of HL237 and is intended to evaluate the safety, tolerability and pharmacokinetics of each dose group.
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.
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
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HL237 200mg
Arm Type
Experimental
Arm Description
HL237 100mg 1 tablet twice a day
Arm Title
HL237 400mg
Arm Type
Experimental
Arm Description
HL237 100mg 2 tablets twice a day
Arm Title
HL237 800mg
Arm Type
Experimental
Arm Description
HL237 400mg 1 tablet twice a day
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
14days after administration
Title
Area Under the Curve [AUC]
Description
AUC after the drug has been administrated
Time Frame
14days after administration
Title
Half life [t1/2]
Description
Half life after the drug has been administrated
Time Frame
14days after administration
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
Adverse Adverse Events, Serious 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seunghun Han
Phone
82-2-2258-7326
Email
waystolove@catholic.ac.kr
Facility Information:
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seunghun Han
12. IPD Sharing Statement
Learn more about this trial
A Multiple Dose of HL237 in Healthy Male Subject
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